[{"@context":"https://schema.org","@type":"JobPosting","title":"Sr. Design Quality Engineer","description":"At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com\n\nJob Function:\nQuality\n\nJob Sub Function:\nR&D/Scientific Quality\n\nJob Category:\nProfessional\n\nAll Job Posting Locations:\nDanvers, Massachusetts, United States of America\n\nJob Description:\n\nAbout MedTech\n\nFueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.\n\nYour unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech\n\nWe are searching for the best talent for Sr. Design Quality Engineer role to be located at Danvers, MA.\n\nThe ideal candidate for the Design Quality Engineer position will support various New Product Development and sustaining activities as well as play a role in product risk management, cybersecurity, change controls, and design controls.\n\nThis engineer should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility. Be ready to make a significant contribution to a dynamic, fun, multi-disciplinary team, where a self-motivated engineer with excellent written and verbal communication skills stands ready to succeed.\n\nSeize the opportunity today to join this collaborative, high performing team within the fastest growing business in MedTech. Come join our Abiomed team today!\n\nKey Responsibilities:\n• Provide Design Quality Engineering support throughout the product development lifecycle ensure compliance with regulations and internal Quality Management System procedures.\n• Provide support to new product development and sustaining engineering projects including review and approval change orders.\n• Use technical expertise, knowledge, and experience to rapidly innovate the companies’ medical devices for use in chronic heart failure patients.\n• Facilitate and conduct risk management activities including development of Risk Management Plans, Hazard Analyses, Design Failure Modes and Effects Analysis () and Risk Management Reports.\n• Participate in reviewing design inputs and design output requirements, ensure risk control measures and cybersecurity requirements are transformed into product requirements.\n• Participate in V&V activities, review verification and validation plan, test protocol reports.\n• Participate in product cybersecurity activities including product security planning, threat analysis, cybersecurity risk assessments, periodic monitoring and reporting.\n• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities.\n• Contribute to the success of the Quality System performance measures by completing tasks on time and with a high level of Quality\n• Provide support during Corrective and Preventive Action (CAPA) activities and manage the CAPA system as necessary.\n• Support 3rd party audits, including follow-up on actions and quality department initiatives.\n• Ensure compliance of QMS through authoring and updating Standard Operating Procedures (SOP).\n\nQualifications\n\nEducation:\n• A minimum of a bachelor’s degree in engineering or scientific discipline is required. An advanced degree in a related field is also an asset.\n\nExperience and Skills\n\nRequired:\n• Minimum 5 years of work experience in a highly regulated industry is required or equivalent to a master’s degree in engineering or scientific discipline. Medical Device and/or Biotechnology industry is preferred.\n• Working experience and Knowledge of quality system regulation, including 21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP and/or MDD/MDR.\n• Experience conducting and furnishing RMF and Design Failure Mode Effects and Analysis\n• Demonstrated and impactful experience in design control and risk management activities.\n• Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team and international.\n\nPreferred:\n• Work experience in electro-mechanical devices.\n• Familiar and working experience in CI tools, reliability and statistical sample size\n\nOther:\n• This position will require working onsite in Danvers, MA with a minimum of 3 days per week and will require 10% of domestic and/or international travel.\n\nJohnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disabili","datePosted":"7 hours ago","hiringOrganization":{"@type":"Organization","name":"6942-ABIOMED Legal Entity"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Cherry Hill Township","addressRegion":"New Jersey","addressCountry":"US"}},"employmentType":"FULL-TIME_AND_CONTRACTOR","directApply":true,"baseSalary":{"@type":"MonetaryAmount","currency":"USD","value":{"@type":"QuantitativeValue","minValue":109000,"maxValue":175000,"unitText":"YEAR"}}},{"@context":"https://schema.org","@type":"JobPosting","title":"Sr. CAPA Quality Engineer","description":"Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.\n\nJob Description\n\nWorking at Abbott\n\nAt Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:\n• Career development with an international company where you can grow the career you dream of.\n• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.\n• An excellent retirement savings plan with a high employer contribution\n• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.\n• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.\n• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.\n\nThe Opportunity\n\nPersonalized healthcare is the future. Bio-wearable technology will digitize, decentralize, and democratize healthcare, enabling consumers to take control of their own health. Diabetes is a growing problem worldwide, and at Abbott Diabetes Care (ADC) we are helping people with diabetes lead healthier, happier lives.\n\nConsistent and accurate glucose monitoring is the foundation of any diabetes management plan, and we‘re committed to continuous improvement in the way patients and professionals measure, track and analyze glucose levels. ADC is responsible for the development and launch of new digital products based on the FreeStyle Libre platform, the world’s #1 continuous glucose monitoring (CGM) solution.\n\nThis position will be based out of Abbott Diabetes Care Division in Alameda, CA and the individual will be expected to be onsite Mon-Fri. The position will be responsible for driving CAPA projects through its entire life cycle, mentor lower-level engineers, while strategizing continuous process improvements that aid in improving the CAPA program.\n\nWhat You’ll Work On\n• Lead, mentor and motivate a team of Quality Engineers.\n• Communicate confidently and effectively with all levels of management, peers, and key stakeholders, including timely escalation of quality issues.\n• Accountable for leadership and oversight of the CAPA system, and associated deliverables.\n• Provide guidance, insight and training to the team and the wider business around CAPA process, quality standards, and regulatory requirements.\n• Lead and/or contribute to continuous improvement initiatives and projects.\n• Provide subject matter expertise during audits and inspections.\n• Represent CAPA QA in cross functional meetings (site and division).•\n• High proficiency leading meetings and communications for QA system information, concerns, and updates.\n• Lead, develop, and mentor others with QA data analysis, trending, and reporting. High proficiency with reporting and publishing weekly, monthly, and quarterly metrics.\n• Adept at staying current with organizational and industry information and routinely mentors/leads other members of the organization on quality assurance practices.\n• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.\n\nRequired Qualifications\n• B.S. in Engineering, Technical Field, Life Science or closely related discipline. Equivalent combination of education and work experience will be accepted\n• Minimum 6 years in Quality or related field experience.\n• Previous CAPA and/or Quality Assurance/engineering experience and demonstrated use of quality tools/methodologies.\n\nPreferred Qualifications\n• Prior medical device experience\n• Masters degree\n• Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485: 2016.\n• Solid communication and interpersonal skills.\n• Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.\n• Advanced computer skills, including statistical/data analysis and report writing skills.\n• Ability to work in a highly matrixed and geographically diverse business environment.\n• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.\n• Ability to leverage and/or engage others to accomplish projects.\n• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.\n• Multitasks, prioritizes and me","datePosted":"22 hours ago","hiringOrganization":{"@type":"Organization","name":"Abbott Laboratories","sameAs":"https://www.abbott.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Berkeley","addressRegion":"California","addressCountry":"US"}},"employmentType":"FULL-TIME","directApply":true},{"@context":"https://schema.org","@type":"JobPosting","title":"Director, Vascular Medical Affairs & Scientific Publications","description":"Additional Location(s): N/A\n\nDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance\n\nAt Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.\n\nAbout the role:\n\nWe are seeking a strategic and visionary leader to oversee Vascular Medical Affairs, Scientific Affairs, and Scientific Communications (Publications). This leader will ensure alignment with therapeutic and business goals, while maintaining competitive awareness and advancing Boston Scientific’s leadership in the medical device industry.\n\nThis role requires strong cross-functional collaboration with executive and clinical teams to ensure the integrity of clinical data communication. The successful candidate will lead teams responsible for external engagement, evidence generation, and scientific communications, ensuring alignment with regulatory standards and publication excellence.\n\nWork model, sponsorship, relocation:\n\nAt Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.\n\nYour responsibilities will include:\n• Lead and develop a high-performing team in interpreting clinical data and trial designs to identify evidence gaps and strategic opportunities within the vascular space.\n• Set and align scientific and communication strategies with therapeutic area goals, leveraging clinical trends and unmet needs to drive impactful publications and education initiatives.\n• Ensure the team effectively translates complex scientific data into clear, accurate, and compelling content for diverse internal and external audiences.\n• Drive cross-functional collaboration with Clinical, Regulatory, R&D, and Marketing to ensure scientific messaging is integrated into overarching business strategies.\n• Cultivate and maintain strong relationships with key opinion leaders (KOLs), fostering collaboration and embedding best practices across medical marketing, clinical, and sales functions.\n• Provide strategic leadership across Medical Affairs, Scientific Affairs, and Scientific Communications to ensure team alignment with clinical and organizational objectives.\n• Oversee the creation and delivery of scientific content, including peer-reviewed publications, conference presentations, and medical education programs.\n• Serve as a trusted advisor and thought leader to internal and external stakeholders, contributing to initiatives that enhance therapy adoption and reinforce scientific credibility.\n\nQualifications:\n\nRequired qualifications:\n• Bachelor's degree\n• 10+ years' experience in a related field\n• 5+ years' experience in clinical education\n• 5+ years' experience in team or people management\n• Ability to travel up to 60% of the time\n• Strategic thinking and planning capabilities\n• Innovative mindset and willingness to support appropriate risk-taking to drive progress\n• Strong collaborative approach with a track record of cross-functional leadership\n• Proven experience in leading, developing, and managing high-performing teams\n• Excellent project management skills\n• Strong clinical, scientific, and technical acumen; comfortable presenting clinical data to physicians\n• Exceptional verbal and written communication and presentation skills\n• Demonstrated ability to build strong relationships and credibility with KOLs and clinical investigators\n• Ability to quickly learn and communicate emerging technologies and data\n\nPreferred qualifications:\n• RN, Master’s, or Doctorate degree in a clinical or scientific field\n\nRequisition ID: 614210\n\nMinimum Salary: $ 143400\n\nMaximum Salary: $ 272500\n\nThe anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.\n\nCompensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and o","datePosted":"23 hours ago","hiringOrganization":{"@type":"Organization","name":"Boston Scientific","sameAs":"https://www.bostonscientific.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Maple Grove","addressRegion":"Minnesota","addressCountry":"US"}},"employmentType":"FULL-TIME","directApply":true},{"@context":"https://schema.org","@type":"JobPosting","title":"Senior Quality R&D Design Engineer","description":"Job Description\n• Our client is a privately held medical device company based in Northern California growing rapidly in the development of disease-modifying therapies that improve survival, quality of life, and outcomes for patients with bronchitis, cardiac conditions, lung cancer, COPD, asthma, and other pulmonary diseases. They are building a portfolio of technologies to address the needs of interventional pulmonologists and radiologists, cardiac and thoracic surgeons, and physicians who treat pulmonary disease.\n• They are seeking a Sr. R&D Engineer Design Controls & Risk Management to support on-going development programs. This role is critical for ensuring robust design practices, regulatory compliance, and effective cross-functional collaboration throughout the product lifecycle. The position will focus on authoring/owning requirement documents, traceability matrix, and Risk Management documents, while also managing external vendor/supplier activities such as Transit/Environmental Testing, Sterilization, and Biocompatibility testing.\n\nResponsibilities:\n• Prepare and present structured technical documentation and summaries for internal and external stakeholders.\n• Lead the development, documentation, and maintenance of Design Control elements including User Needs, Design Inputs/Outputs, DV protocols, test cases, and reports.\n• Create and maintain Risk Management documentation in accordance with ISO 14971 (Design, Use-Related, Process, Software).\n• Manage and maintain the Input/Output Trace Matrix using JAMA Software, ensuring alignment between requirements, risks, and V&V activities.\n• Collaborate cross-functionally with R&D, Quality, Regulatory, Clinical, and Operations teams to ensure cohesive development and regulatory alignment.\n• Participate in and/or lead formal design reviews, risk reviews, and test planning sessions.\n• Provide input and oversight for Design Verification testing to ensure coverage of requirements and risk mitigations.\n• Support updates to design control and risk documentation during design changes, sustaining engineering, or complaint investigations.\n• Ensure compliance with applicable standards including 21 CFR Part 820, ISO 13485, and ISO 14971.\n• Drive continuous improvement of design control and risk management processes to enhance efficiency and compliance.\n\nRequirements:\n• Bachelor's or advanced degree in Mechanical or Biomedical Engineering (other engineering disciplines considered with medical device experience).\n• 5+ years of experience developing or supporting capital equipment and/or disposable medical devices (energy-based device space preferred).\n• Proven experience authoring and managing requirements, traceability matrix, and risk documentation.\n• Strong knowledge of Design Control and Risk Management requirements under FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971.\n• Proficiency in authoring risk assessment documents (e.g., FMEA) and understanding risk methodologies.\n• Strong attention to detail with a systematic approach to documentation and traceability.\n• Excellent organizational and communication skills with the ability to manage multiple priorities.\n• Familiarity with CAD software and testing tools a plus.\n\nTravel & Location:\n• Onsite in Redwood City, CA with flexibility to work in a hybrid capacity.\n• Domestic and international travel (less than 20%) to collaborate with external vendors and support clinical trials when necessary.","datePosted":"1 day ago","hiringOrganization":{"@type":"Organization","name":"Katalyst CRO","logo":"https://encrypted-tbn0.gstatic.com/images?q=tbn:ANd9GcTFlkgZE_ntUzeeXUJYGNTHfSe0yWGlAhbraPyz&s=0"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Redwood Terrace","addressRegion":"California","addressCountry":"US"}},"employmentType":"FULL-TIME","directApply":true},{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Engineer I - Medical Device Quality & Compliance","description":"A clinical laboratory company in Denver is seeking a Quality Assurance Associate to provide quality assurance support for In-Vitro Diagnostics. The ideal candidate will maintain the Quality Management System and ensure compliance with various regulatory standards. Responsibilities include conducting audits, documenting nonconformities, and collaborating across teams to improve quality processes. Successful applicants should hold a degree in engineering and have strong analytical skills. Competitive annual salary between $60,000 and $80,000 offered.\n\n#J-18808-Ljbffr","datePosted":"2 days ago","hiringOrganization":{"@type":"Organization","name":"HepQuant","sameAs":"https://hepquant.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Denver","addressRegion":"Colorado","addressCountry":"US"}},"employmentType":"FULL-TIME","directApply":true},{"@context":"https://schema.org","@type":"JobPosting","title":"Senior Supplier Quality Engineer: Global Medical Device QA","description":"Job Description\n\nA leading medical device company seeks a Senior Supplier Quality Engineer to oversee quality management systems and collaborate with suppliers in Marlborough.\n• 6+ years experience in a regulated industry\n• Strong project management skills\n• BS degree in engineering\n\nThis role requires onsite work and offers a competitive salary ranging from $86,600 to $164,500. A problem-solver committed to patient safety is encouraged to apply.","datePosted":"2 days ago","hiringOrganization":{"@type":"Organization","name":"Boston Scientific Gruppe"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Marlborough","addressRegion":"Massachusetts","addressCountry":"US"}},"employmentType":"FULL-TIME","directApply":true},{"@context":"https://schema.org","@type":"JobPosting","title":"Onsite Quality Engineer I – Medical Devices","description":"Job Description:\n\nAs a Quality Engineer I, you will ensure compliance with quality standards and contribute to product launches.\n• Operate onsite at our medical device company in California\n• Work Monday through Friday\n\nThe ideal candidate has experience in a GMP or FDA-regulated environment and demonstrates knowledge of Quality Engineering principles.","datePosted":"2 days ago","hiringOrganization":{"@type":"Organization","name":"Tandem Diabetes Care","logo":"https://encrypted-tbn0.gstatic.com/images?q=tbn:ANd9GcS-PMIj8CwC9jq5eUwB_1YkdTBTRnHAh7Rcuf_Z&s=0","sameAs":"https://www.tandemdiabetes.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"California","addressRegion":"Missouri","addressCountry":"US"}},"employmentType":"FULL-TIME","directApply":true},{"@context":"https://schema.org","@type":"JobPosting","title":"Regulatory Affairs Consultant (Dallas, TX)","description":"Regulatory Affairs Consultant\n\nLocation: Hybrid (Dallas, TX Preferred)\n\nYrs of Exp: 3 yrs +\n\nOverview:\n\nWe are seeking a highly skilled and detail-oriented Regulatory Consultant to join our dynamic team in the medical device sector. This role will provide expert guidance on navigating complex regulatory landscapes, ensuring compliance with global medical device regulations, and facilitating market entry strategies. The ideal candidate will have extensive experience in regulatory affairs within the medical device industry, with a focus on preparing submissions, maintaining compliance, and providing strategic advice to internal stakeholders.\n\nResponsibilities:\n\nRegulatory Strategy Development:\n\nDevelop and implement regulatory strategies for medical devices, ensuring compliance with global regulations (FDA, EU MDR, Health Canada, TGA, etc.).\n\nAdvise on the appropriate regulatory pathways (e.g., 510(k), PMA, CE marking) based on device classification and target markets.\n\nRegulatory Submissions & Documentation:\n\nPrepare and review regulatory submission documents, including 510(k) notifications, PMA applications, CE technical files, clinical evaluation reports (CERs), and other regulatory filings for various markets.\n\nEnsure timely and accurate submission of documents to relevant regulatory bodies.\n\nDevice Classification & Risk Assessment:\n\nWork with cross-functional teams to classify devices according to relevant regulatory frameworks (FDA, EU, etc.).\n\nConduct risk assessments to determine the appropriate level of regulatory oversight required.\n\nCompliance and Quality Systems:\n\nEnsure company's products meet all regulatory requirements, including adherence to quality management standards such as ISO 13485 and FDA QSR (Quality System Regulations).\n\nConduct gap analysis and recommend improvements to existing systems.\n\n- Clinical Evaluation & Trial Support:\n\nProvide guidance on the design, implementation, and regulatory requirements for clinical trials to support safety and efficacy claims.\n\nEnsure clinical data meets the regulatory standards required for submission. - Labeling and Documentation Compliance:\n\nReview labeling, packaging, and instructions for use (IFU) to ensure they comply with regulatory requirements and accurately reflect product claims.\n\nAdvise on the regulatory impact of any changes to labeling.\n\n- Post-Market Surveillance:\n\nSupport post-market surveillance activities, including adverse event reporting, vigilance reporting (e.g., MDR in Europe), and periodic reviews of product performance in the market.\n\nAssist in the preparation of periodic regulatory updates and renewals.\n\n- Regulatory Audits and Inspections:\n\nAssist in preparing for and supporting regulatory inspections and audits by agencies such as FDA, EMA, and Notified Bodies.\n\nAct as a liaison with regulatory authorities during inspections, responding to queries and providing necessary documentation.\n\n- Global Regulatory Affairs:\n\nProvide guidance on the regulatory requirements for entry into international markets, ensuring timely and successful product registrations in regions such as the EU, Canada, Asia-Pacific, and Latin America.\n\n- Training & Education:\n\nConduct internal training sessions on regulatory requirements, trends, and best practices for medical devices.\n\nProvide guidance to cross-functional teams (e.g., R&D, marketing, manufacturing) on regulatory matters.\n\n-\n\nQualifications:\n\n- Education:\n\n- Bachelor's degree in Life Sciences, Engineering, or a related field (required). Advanced degree (e.g., Master's, PhD, or Regulatory Affairs Certification (RAC)) is a plus.\n\n- Experience:\n\n- Minimum of 3 years of experience in regulatory affairs, specifically within the medical device industry. Experience with both Class I, II, and III devices is preferred.\n\n- Proven track record of successful regulatory submissions and approvals (e.g., FDA 510(k), PMA, CE marking).\n\n- Experience with international regulations (e.g., EU MDR, TGA, Health Canada) and global market access strategies.\n\n- Technical Skills:\n\n- In-depth knowledge of regulatory requirements for medical devices (FDA, EU MDR, Health Canada, etc.).\n\n- Familiarity with ISO 13485 and other quality management system standards.\n\n- Strong understanding of clinical trial design and the role of clinical data in regulatory submissions.\n\n- Proficient in regulatory software tools and databases.\n\n- Communication Skills:\n\n- Excellent written and verbal communication skills. Ability to write clear and concise regulatory documents and reports.\n\n- Strong presentation and interpersonal skills, with the ability to interact with regulatory authorities, internal teams, and external partners.\n\n- Problem Solving:\n\n- Strong analytical and problem-solving abilities, with attention to detail and the ability to interpret complex regulations.\n\n- Ability to think strategically and provide creative solutions to regulatory challenges.\n\n- Other:\n\n- Knowledge of international standards and best practices (e.g.","datePosted":"2 days ago","hiringOrganization":{"@type":"Organization","name":"Cedent","logo":"https://encrypted-tbn0.gstatic.com/images?q=tbn:ANd9GcSUqE3YKAUxDrW5WZwu2firxsLi4prVzlG5vnms&s=0","sameAs":"https://cedentinc.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Dallas","addressRegion":"Texas","addressCountry":"US"}},"employmentType":"FULL-TIME","directApply":true},{"@context":"https://schema.org","@type":"JobPosting","title":"Medical Device Engineer","description":"Job Title: Medical Device EngineerJob Description\n\nLead the development of electromechanical medical device products, overseeing the process from design through to systems and quality assurance. This role requires a balance of onsite and remote work, with 3 days per week in the office in the Racine, Wisconsin area and 2 days working remotely.\nResponsibilities\n• Lead and manage critical activities to maintain and improve electro-mechanical medical device design, manufacturing, and service processes.\n• Participate in reliability studies and lead troubleshooting activities to investigate root causes and resolve product complaints and CAPA.\n• Provide alternatives to end-of-life for electrical components.\n• Conduct research and testing to solve problems, testing functionality, safety, and effectiveness.\n• Develop prototypes and conduct testing to ensure devices meet customer needs, design requirements, and regulatory standards.\n• Collaborate closely with cross-functional teams, including mechanical engineers, process engineers, quality, and regulatory teams, to ensure device safety, compliance, and functionality.\n• Ensure device compliance with relevant regulations and standards, such as FDA, IEC series, and GMP.\n• Develop detailed electrical drawings and document design processes and test results.\n• Execute the Engineering Change Order (ECO) process according to Design Controls – Design Change regulations and internal policies.\n• Support regulatory submissions and mentor junior electrical engineers.\nEssential Skills\n• 10+ years of experience in electrical engineering with a focus on medical devices.\n• Strong skills in root cause analysis and electrical design.\n• Experience in quality assurance and systems engineering.\n• Ability to address machine-related and broader device or therapy-related problems.\nAdditional Skills & Qualifications\n• Bachelor's Degree in Electrical Engineering.\n• 7+ years of electrical engineering experience in the medical device field.\n• Experience with printed circuit board design and analysis.\n• Proficiency with Altium Designer or other electrical PCB design software.\n• Understanding of process validation and statistical analysis.\n• Knowledge of quality management system requirements.\n• Understanding of FDA Design Controls and EU Medical Device Directive requirements.\n• Familiarity with electro-mechanical manufacturing, depot service, and field service processes and operations.\n• Experience with system-level requirements definition.\nWork Environment\n\nThe role includes a hybrid work model with 3 days per week onsite at the office in Racine, Wisconsin and 2 days remote. The position involves collaboration with diverse teams and requires adherence to regulatory standards. The company offers a competitive annual bonus of up to 15%.\nJob Type & Location\n\nThis is a Permanent position based out of Franksville, WI.\nPay and Benefits\n\nThe pay range for this position is $110000.00 - $130000.00/yr.\n\nexcellent benefits, 15% annual bonus and growing company and product in demand. flexibility to work remotely 2 days/week\nWorkplace Type\n\nThis is a hybrid position in Franksville,WI.\nApplication Deadline\n\nThis position is anticipated to close on Dec 26, 2025.\nAbout Actalent\n\nActalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.\n\nThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.\n\nIf you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.","datePosted":"2 days ago","hiringOrganization":{"@type":"Organization","name":"Talentify","sameAs":"https://www.talentify.io"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Elkhorn","addressRegion":"Wisconsin","addressCountry":"US"}},"employmentType":"FULL-TIME","directApply":true,"baseSalary":{"@type":"MonetaryAmount","currency":"USD","value":{"@type":"QuantitativeValue","minValue":110000,"maxValue":130000,"unitText":"YEAR"}}},{"@context":"https://schema.org","@type":"JobPosting","title":"Director, Medical Affairs","description":"Job Description\n\nJob Description\n\nAbout Us\n\nWe are a global team of like-minded Med-Tech professionals focused on patient centric solutions in a collaborative environment leading to excellent outcomes. We have developed an advanced and unique heart failure therapy technology in the BrioVAD® Left Ventricular Assist System (LVAS). We are introducing the BrioVAD LVAS to Heart Failure clinicians for use with the large number of indicated and untreated patients who could benefit from chronic mechanical circulatory support. The initiation of our INNOVATE™ Trial in the US is only the beginning. We are building a team to develop advanced technology intended to further improve patient outcomes, increase therapy acceptance, and enabling chronic MCS therapy to be accessible to more patients across the globe.\n\nJob Summary\n\nThe Director, Medical Affairs will play a critical role in shaping BrioHealth’s scientific and clinical communication strategy. Serving as a key bridge between R&D, Clinical, Regulatory, and Commercial teams, this role will drive dissemination of scientific evidence, strengthen investigator and KOL engagement, and advance the company’s global publication and education initiatives.\n\nReporting to the Vice President, Medical Affairs, the Director will oversee BrioHealth’s publication and presentation programs across both U.S. and international activities.\n\nResponsibilities\n\nScientific Communication & Publications\n\nManage the Publication Committee (CTee): Oversee publication planning, authorship strategy, and manuscript review process in collaboration with cross-functional stakeholders. Journal Watch: Curate and summarize the most relevant peer-reviewed publications for internal distribution to ensure the organization remains up-to-date on emerging science and trends. Journal Club: Organize and manage regular (monthly or bimonthly) Journal Club sessions to foster cross-functional learning among client-facing, clinical, and R&D teams. Data Sharing & Transparency: Define and maintain BrioHealth’s data sharing plan, ensuring compliance with business goals, ethical standards, and global regulatory requirements. Medical Guidelines: Lead development of device management and patient management guidelines in alignment with evolving clinical data and post-market insights.\n\nExternal Engagement & Representation\n\nEngage with Key Opinion Leaders (KOLs), Principal Investigators (PIs), professional societies, and advisory boards to strengthen BrioHealth’s scientific visibility. Represent BrioHealth at major medical conferences, symposia, and professional forums. Partner with investigators on sub-studies, data presentations, and publication opportunities.\n\nCross-Functional Collaboration\n\nLiaise closely with:\nClinical Engineering – Ensure consistency between product development, clinical application, and feedback integration. Clinical Affairs – Collaborate on sub-study protocols, data management, and trial execution. Sales and Marketing – Align scientific communications with commercial messaging, field training, and market education. Training and Education – Maintain accurate, current, and compliant medical content for internal and external training programs. European Activities – Coordinate with regional teams to ensure global alignment on medical communication and data dissemination. Data Insights – Support development and interpretation of medical dashboards, data visualization, and performance metrics.\n\nLeadership & Strategy\n\nBuild collaborative partnerships across internal functions to ensure consistency and quality in scientific messaging. Contribute to annual medical affairs strategy planning, including publication timelines, resource allocation, and budget oversight. Ensure all medical communications are compliant with internal SOPs and external regulatory requirements.\n\nQualifications\n\nAdvanced degree (MD, PharmD, PhD, MSN) in a clinical or scientific discipline, or equivalent. 8+ years of experience in Medical Affairs with a strong foundation in medical device development, clinical trial support, and scientific communication; experience with cardiovascular or Class III implantable devices preferred. Demonstrated success managing publications, data dissemination, or medical communication programs in a regulated environment. Proven ability to engage with KOLs, advisory boards, and clinical investigators to translate evidence into clinical practice and education. Strong knowledge of Good Publication Practice (GPP), authorship standards, and ethical data-sharing principles. Excellent analytical and communication skills, with the ability to distill complex clinical and scientific data into clear, actionable messages. Experienced in cross-functional collaboration with R&D, Clinical, Regulatory, and Commercial teams. Highly organized, proactive, and comfortable managing multiple priorities in a dynamic, fast-growing organization.","datePosted":"3 days ago","hiringOrganization":{"@type":"Organization","name":"BrioHealth Solutions Inc.","sameAs":"https://briohealthsolutions.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Burlington","addressRegion":"North Carolina","addressCountry":"US"}},"employmentType":"FULL-TIME","directApply":true},{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Engineer I","description":"B. Braun Medical, Inc.\nCompany: B. Braun US Device Manufacturing LLC\nJob Posting Location: Allentown, Pennsylvania, United States\nFunctional Area: Quality\nWorking Model: Onsite\nDays of Work: Friday, Thursday, Wednesday, Tuesday, Monday\nShift: 5X8\nRelocation Available: No\nRequisition ID: 8695\n\nB. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.\n\nGlobally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.bbraunusa.com\n\nPosition Summary:\n\nProvide full quality support and expertise to others to achieve a high level of quality material, product, process, and test methods. Managing and performing root cause analysis and investigation studies for nonconformances, CAPAs and complaint trends. Serve as QA representative for material review board (MRB) meetings. Owner and execute quality improvement change controls. Provide risk assessment and an accurate action plan/solution that immediately mitigates impact on Quality and Production KPIs. Lead and execute equipment installation, qualification, and test method validation activities.\n\nResponsibilities: Essential Duties\n• Establishes quality standards for products and processes and suggest modifications meant to prevent defects in components or final products.\n• Works closely with cross functional teams, including product design, product management and production, to identify and mitigate quality risks.\n• Audits production processes, raw materials or suppliers/vendors to ensure that established quality standards are met.\n• Conducts root cause analysis for defects, non conformities or other quality failures.\n• May be responsible for ensuring compliance with formal external quality standards, such as ISO 9001.\nThe job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.\n\nExpertise: Knowledge & Skills\n• Requires full working knowledge of relevant business practices and procedures in professional field. Uses standard theories, principles and concepts and integrates them to propose a course of action.\n• Works under general supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, assigning & checking the work of other peers.\n• Judgement is required in resolving all day-to-day problems.\n• Contacts are primarily with department supervisors, leads, subordinates, and peers. Occasional contact with external contractors/vendors.\n\nExpertise: Qualifications - Experience/Training/Education/Etc.\n\nRequired:\n• 2-4 years related experience required\n• Bachelor's Degree required\n\nDesired:\n• Applicable industry/professional certification preferred.\nAdditional Requirement:\n• Occasional business travel required\n• Attendance Requirement Regular and predictable attendance\n\nWhile performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.\n\nResponsibilities: Other Duties:\n\nThe preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.\n\nPhysical Demands:\n\nWhile performing the duties of this job, the employee is expected to:\n• Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.\n\nLifting, Carrying, Pushing, Pulling and Reaching:\n• Occasionally:Reaching upward and downward, Push/pull\n• Frequently:Stand, Sit\n• Constantly:N/A\n\nActivities:\n• Occasionally:Finger feeling, Handling, Hearing - ordinary, fine distinction, loud (hearing protection re","datePosted":"3 days ago","hiringOrganization":{"@type":"Organization","name":"B. Braun US Device Manufacturing LLC","sameAs":"https://www.bbraunusa.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Raubsville","addressRegion":"Pennsylvania","addressCountry":"US"}},"employmentType":"FULL-TIME","directApply":true},{"@context":"https://schema.org","@type":"JobPosting","title":"Validation Engineer - Medical Devices; ISO/GMP","description":"Position: Validation Engineer - Medical Devices (ISO13485/GMP)\nA client in Fairfield, NJ is seeking a Validation Engineer for a full-time position. The role focuses on preparing Validation/PPAP packages and ensuring compliance with industry standards. Candidates should have a 4-year engineering degree and at least 5 years of experience in product quality, particularly in the medical device sector. The position offers a competitive salary and comprehensive benefits.\n#J-18808-Ljbffr","datePosted":"3 days ago","hiringOrganization":{"@type":"Organization","name":"PrideStaff","sameAs":"https://www.pridestaff.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Fairfield","addressRegion":"New Jersey","addressCountry":"US"}},"employmentType":"FULL-TIME","directApply":true,"baseSalary":{"@type":"MonetaryAmount","currency":"USD","value":{"@type":"QuantitativeValue","minValue":80000,"maxValue":95000,"unitText":"YEAR"}}},{"@context":"https://schema.org","@type":"JobPosting","title":"Medical Device Quality Engineer","description":"Location: Harvard\n\nMedical Device Quality Engineer –\nKatalyst CRO\nSummary\n\nSeeking an experienced Medical Device Quality Engineer to support the launch of a new product into production. The role focuses on process validation and ensuring compliance with medical device quality and regulatory standards.\nRoles & Responsibilities\n• Develop and execute process validation plans, protocols, and reports for new and existing manufacturing processes.\n• Lead PFMEA sessions to identify, assess, and mitigate process and product risks.\n• Design, validate, and verify test methods to ensure product quality and regulatory compliance.\n• Perform and analyze IQ, OQ, PQ qualifications and other validation activities.\n• Collaborate with cross-functional teams (Quality, Engineering, Manufacturing) to drive continuous improvement and resolve production issues.\n• Analyze validation data and recommend process optimizations based on findings.\n• Write and maintain SOPs, work instructions, and process documentation to support repeatable, high-quality production and regulatory audits.\n• Maintain validation and quality documentation in accordance with internal procedures and applicable regulatory requirements.\nEducation & Experience\n• 10+ years of experience in process validation (medical device experience required; not pharma).\n• Hands‑on experience with IQ, OQ, PQ and FMEAs.\n• Orthopedic device experience preferred.\n• Strong understanding of regulatory compliance and quality standards applicable to medical devices.\n• Proven ability to develop validation protocols/reports and maintain controlled documentation.\n• Self‑starter with excellent problem‑solving skills.\n• Ability to work independently and collaboratively in a fast‑paced manufacturing environment.\nLocation\n\nDevens, MA (Onsite, 5 days/week).\nSeniority Level\n• Mid‑Senior level\nEmployment Type\n• Contract\n#J-18808-Ljbffr","datePosted":"3 days ago","hiringOrganization":{"@type":"Organization","name":"Katalyst CRO"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Harvard","addressRegion":"Massachusetts","addressCountry":"US"}},"employmentType":"FULL-TIME","directApply":true},{"@context":"https://schema.org","@type":"JobPosting","title":"Clinical Affairs Lead Analyst (Ultrasound)","description":"Work Flexibility: Remote\n\nThe Clinical Affairs Lead Analyst plays a key role in Medical Education, supporting teams with high-quality, on-site and remote ultrasound training to ensure consistent, reliable imaging for total portfolio vascular care with an emphasis on TADV. Partnering closely with cross-functional groups and the commercial sales team, this position strengthens protocol adherence, enhances training impact, and helps maintain best-practice standards across all participating sites. This position is Remote with 75% travel requirements.\n\nWhat you will do\n• Deliver clinical training programs for sonographers, physicians, and clinical staff related to ultrasound surveillance for TADV therapy and peripheral vascular disease states.\n• Assist in the continuous improvement of ultrasound protocols and best practices.\n• Provide onsite and remote clinical support and guidance to participating sites, ensuring the quality and consistency of ultrasound images for accurate diagnosis and treatment.\n• Maintain thorough knowledge of clinical workflow, patient care considerations, and operational requirements.\n• Commitment to maintaining a high level of professionalism, clinical quality, and patient safety.\n• Flexibility and resourcefulness in adapting to clinical site needs and evolving therapy requirements.\n• Ability to build collaborative relationships across clinical, technical, and operational teams.\n• Maintain accurate documentation of training, site support, and clinical observations.\n• Participate in meetings, site visits, and other activities related to clinical education and therapy advancement.\n• Assist in Vascular training content creation.\n\nWhat you need\n• Bachelor’s degree or equivalent in science or health care related field.\n• Relevant clinical experience specifically in Medical Device or Pharmaceutical industry.\n• Minimum of 4 years of experience in clinical ultrasound, medical imaging, healthcare education, or a related healthcare or science field.\n• Strong clinical and technical knowledge of vascular sonography, including hemodynamics, ultrasound physics, deep venous and arterial duplex assessments, and physiologic studies.\n• Experience in Vascular Sonography coding.\n• Direct vascular interventional experience in the OR, Cath Lab, IR suite, or Office Based Lab.\n• Willingness to travel extensively (>75%), including to clinical sites, meetings, and training.\n\nPreferred Qualifications\n• ARDMS RVT or CCI RVS credential and certification active.\n• Higher education degree from an accredited vascular ultrasound program (4 years of clinical vascular ultrasound experience).\n• Strong critical thinking, problem solving, and creative abilities to support clinical teaching and protocol adherence.\n• $96,400 - $158,000 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.\n\nPosted: November 18, 2025\n\nTravel Percentage: 70%\n\nStryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.\n\nStryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.","datePosted":"3 days ago","hiringOrganization":{"@type":"Organization","name":"Stryker","logo":"https://encrypted-tbn0.gstatic.com/images?q=tbn:ANd9GcQUGe9UK2YYuVUNaI-OolVqEmzd8vvG8epYzqrS&s=0","sameAs":"https://www.stryker.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressRegion":"California","addressCountry":"US"}},"jobLocationType":"TELECOMMUTE","employmentType":"FULL-TIME","directApply":true,"baseSalary":{"@type":"MonetaryAmount","currency":"USD","value":{"@type":"QuantitativeValue","minValue":96400,"maxValue":158000,"unitText":"YEAR"}}},{"@context":"https://schema.org","@type":"JobPosting","title":"Director, Medical Devices & Combination Products","description":"Application deadline:\nLocation: Madison 07940, New Jersey, United States\nContract type: Permanent\nJob ID: 4025\n\nRole Description\n\nYour Role\n\nAs Director, Medical Devices & Combination Products, you will shape global regulatory CMC strategy for our development and commercialized device combination products. You will translate governance decisions into actionable regulatory roadmaps that accelerate market access, support efficient submissions and approvals, and ensure compliance with FDA, EMA, EU MDR, and other applicable global standards.\n\nYour Responsibilities\nDevelop, plan and execute global regulatory strategies for Drug Device Combination Products in development and during life-cycle maintenance: ensuring alignment with FDA (21 CFR Parts 3/4/801/820), EMA/EC (EU MDR and Article 117), and relevant ISO standards .\nAuthority engagement: lead and negotiate with FDA (including OCP), EMA/EC, Competent Authorities, and Notified Bodies; secure NB opinions and align on evidence requirements;\nTranslate governance decisions into executable regulatory roadmaps with clear timelines, deliverables, and cross-functional accountability across Development, Technical functions QA, Clinical Operation, and Commercial.\nAnticipate regulatory risks and opportunities. Develop evidence-based scenarios and mitigations covering design controls, human factors validation, component/supplier changes, and CMC interfaces (extractables/leachable, drug-device compatibility, container closure integrity).\nDrive the strategy for evidence and data generation assessing the requirements for HF studies, biocompatibility matrices, sterilization validation, packaging/distribution validation, software documentation etc. Lead submission excellence and readiness across CMC for combination products to streamline reviews for global filings\nWork with the Global Regulatory Team (GRT) to implement strategies and the Regulatory Project Plan, ensuring alignment across Global Regulatory Affairs (GRA) for combination products.\nProvide regulatory leadership on Drug Device Combination product matters in cross-functional teams, using your expertise in Devices and regulatory insight.\nLead device specific labeling strategy and claims discussion\nEstablish regulatory intelligence initiatives, and policy shaping mechanisms, distilling external guidance into internal recommendations. Engage with Industry bodies to inform and shape policy.\nCollaborate with internal teams across development, Technical functions , QA, clinical, and commercial to streamline submissions and regulatory compliance.\n\nYour Qualifications\n\nA Bachelor's or Master's degree in engineering, pharmaceutical sciences, regulatory affairs, or a related field (an advanced degree is preferred).\n12+ years of increasing responsibility in global regulatory affairs for Drug Device Combination Products with a proven track record in CMC/technical leadership.\nExpert knowledge of FDA, EMA/EC, EU MDR and global device/combination product regulations, standards, and pathways; deep familiarity with 21 CFR Parts 3/4/801/820; EMA Article 117 processes; NB opinion workflows.\nAdvanced expertise across device standards and evidence: ISO 13485, ISO 14971, ISO 10993 series, ISO 11135/11137, ISO 11607, IEC 62366, IEC 62304; cybersecurity expectations; UDI/EUDAMED and labeling requirements (EU MDR Annex I GSPRs).\nProven leadership of Technical Files/Design Dossiers, PMA/510(k)/De Novo submissions, and integration of combination product requirements into NDA/BLA filings.\nStrong knowledge of CMC-device interfaces, including extractables/leachables, drug-device compatibility, and packaging/sterilization validations.\nExceptional leadership and mentoring skills, with experience in capability building and establishing processes and frameworks for regulatory excellence .\nStrong communication and collaboration skills within cross functional teams. Skilled in negotiationand engagement with Agencies and Notified Bodies.\nProven ability to navigate complex regulatory landscapes, anticipate risks, and influence senior governance decisions.\n\nThe base salary range for this position is $175,000-240,000 per year. The base salary range represents the anticipated low and high of the LEO Pharma range for this position. Salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Certain roles may be eligible to earn commissions/bonus based on company and / or individual performance.\n\nLEO Pharma offers a competitive benefits package including medical, dental, and vision coverage, employer-paid life and disability insurance, a 401(k) retirement plan with employer match; and paid time off.\n\nBeyond the skin\n\nJoin LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact. Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet.\n\nLEO Pharma Inc. is an Equa","datePosted":"3 days ago","hiringOrganization":{"@type":"Organization","name":"Leo Pharma","logo":"https://encrypted-tbn0.gstatic.com/images?q=tbn:ANd9GcSSA9Z6qB7zTha9oPNDNaJKov9eo8KOeVw9tSJu&s=0","sameAs":"https://www.leo-pharma.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Madison","addressRegion":"New Jersey","addressCountry":"US"}},"employmentType":"FULL-TIME","directApply":true,"baseSalary":{"@type":"MonetaryAmount","currency":"USD","value":{"@type":"QuantitativeValue","minValue":175000,"maxValue":240000,"unitText":"YEAR"}}},{"@context":"https://schema.org","@type":"JobPosting","title":"Medical Director, CRM Medical Affairs","description":"Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.\n\nWORKING AT ABBOTT:\n\nAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:\n• Career development with an international company where you can grow the career you dream of.\n• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.\n• An excellent retirement savings plan with high employer contribution\n• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree\n• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.\n• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.\n\nTHE OPPORTUNITY:\n\nYou will provide strategic and operational support to the Chief Medical Officer and the broader Cardiac Rhythm Management (CRM) business. This role is essential to expanding the bandwidth of Medical Affairs and will contribute to product development, clinical trial planning and execution, regulatory support, quality oversight, and external engagement with key opinion leaders and professional societies.\n\nWHAT YOU’LL WORK ON:\n• Lead medical affairs activities for the core technology products (transvenous pacemaker (low voltage), transvenous ICD (high voltage), CRT, ICM(ILR), and Merlin.net.\n• Collaborate with R&D on pipeline development and defining new product features.\n• Plan and execute clinical studies (IDE, indication expansion, post-approval registries, real-world evidence).\n• Draft and review scientific publications.\n• Provide medical input for regulatory submissions and health reimbursement strategies globally.\n• Support commercial and marketing initiatives with medical expertise.\n• Monitor product quality, review risk management reports (RMRs), health hazard evaluations (HHEs), and assist in field action execution.\n• Develop and maintain relationships with professional societies, academic medical institutions, and key opinion leaders to advance scientific collaboration and enhance the visibility of CRM initiatives.\n• Serve as medical representative on risk evaluation and investigation teams.\n• Provide initial medical input for customer communications, technical bulletins, and quality directives.\n• Update medical affairs procedural documents and manage change requests.\n\nQUALIFICATIONS:\n• M.D. or D.O. with board certification in Clinical Cardiac Electrophysiology or international equivalent\n• 10+ years of clinical practice with deep expertise in cardiac rhythm management, including CIED implantation and follow-up\n• Comprehensive understanding of electrophysiology, device-based therapies, and cardiac rhythm interventions.\n• Proven experience in medical monitoring, adverse event reporting, and leadership of clinical events committees.\n• Skilled in authoring and reviewing promotional, educational, and scientific materials.\n• Capable of evaluating product complaints and contributing to safety assessments and surveillance activities.\n• Exceptional communication, leadership, and multitasking abilities in fast-paced, cross-functional environments.\n\nAPPLY NOW:\n\nLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com\n\nFollow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.\n\nConnect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal\n\nThe base pay for this position is $193,300.00 – $386,700.00. In specific locations, the pay range may vary from the range posted.","datePosted":"3 days ago","hiringOrganization":{"@type":"Organization","name":"Abbott Laboratories","logo":"https://encrypted-tbn0.gstatic.com/images?q=tbn:ANd9GcQ4F4BqX_1FV8BDQlePPc8fnqxjFPO2We9By3gi&s=0","sameAs":"https://www.abbott.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressRegion":"California","addressCountry":"US"}},"employmentType":"FULL-TIME","directApply":true},{"@context":"https://schema.org","@type":"JobPosting","title":"Medical Writer","description":"Are you passionate about making a difference in the medical device industry? Join our dynamic team at CONMED as a Medical Writer! In this pivotal role, you'll leverage your expertise in global regulations to proactively collect and analyze market and customer feedback on our medical devices. Your work will ensure compliance with Medical Device Regulation (EU 2017/745) and other global standards, driving innovation and excellence in healthcare.\n\nKey Responsibilities:\n• Develop and refine strategies and processes for market and customer feedback collection.\n• Assist in creating medical device market research protocols and Case Report Forms.\n• Craft and update post-market surveillance plans, Periodic Safety Update Reports, and Post Market Surveillance reports.\n• Collaborate with cross-functional teams and surgeons for Post Market Clinical Follow-up studies.\n• Keep relevant procedures up-to-date.\n\nWhat You'll Do:\n• Utilize your knowledge of medical devices and In-Vitro Diagnostic products to gather proactive customer feedback per Medical Device Regulation (EU 2017/745) and In-Vitro Diagnostic Medical Device Regulation (EU 2017/746)\n• Create market research protocols, deploy questionnaires, and compile technical reports.\n• Review and provide feedback on (Periodic Safety Update Reports) and PMSRs (Post-Market Surveillance Reports)\n• Author and update post-market surveillance plans for upcoming and existing medical devices.\n• Interface with engineering, medical, safety, regulatory, quality, and manufacturing teams to complete surveillance activities.\n• Ensure timely creation of deliverables to prevent project delays.\n• Develop proactive customer feedback templates and process workflows.\n• Communicate roadblocks and escalate issues promptly to stakeholders.\n\nQualifications:\n• Associate’s degree in clinical research, health sciences, or a related field.\n• 5+ years of experience with medical devices and/or pharmaceutical industry, preferably in an operating room.\n\nPreferred Skills:\n• Experience with medical device complaint investigation, CAPAs, Recalls, or Post Market Surveillance.\n• Proficiency in creating PMS plans, PMSRs, or PSURs.\n• Strong knowledge of risk management, product design practices, and Good Manufacturing Practices (GMP).\n• Understanding of medical device regulations and adverse event reporting.\n\nThis position is not eligible for employer-visa sponsorship\n\nDisclosure as required by applicable law, the annual salary range for this position is $68,110- $85,000. The actual compensation may vary based on geographic location, work experience, education, and skill level. The salary range is CONMED’s good faith belief at the time of this posting.\n\nThis job posting is anticipated to close on January 23 2025. We may, however, extend this time period, in which case the posting will remain available on careers.conmed.com. Please submit your application as soon as possible as we will be reviewing applications on a rolling basis as we receive them.\n\nBenefits:\n\nCONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.\n• Competitive compensation\n• Excellent healthcare including medical, dental, vision and prescription coverage\n• Short & long term disability plus life insurance -- cost paid fully by CONMED\n• Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period\n• Employee Stock Purchase Plan -- allows stock purchases at discounted price\n• Tuition assistance for undergraduate and graduate level courses\n\nKnow someone at CONMED? Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!\n\nCONMED is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Protected veterans and individuals with disabilities are encouraged to apply. The Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms this commitment.\n\nColorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.\n\nIf you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-929-7176 option #5.","datePosted":"4 days ago","hiringOrganization":{"@type":"Organization","name":"CONMED"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"New York","addressRegion":"New York","addressCountry":"US"}},"employmentType":"FULL-TIME","directApply":true},{"@context":"https://schema.org","@type":"JobPosting","title":"Clinical Affairs Manager - Medical Laser - Marlborough, MA","description":"Back\n117d\n\nClinical Affairs Manager - Medical Laser\n#25-416\n Marlborough, Massachusetts, United States\n Apply \n\n Job Description\n\nIPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. Headquartered in Marlborough, MA, we aspire to work together with our employees and customers to apply light in ways that improve life.\n\nOur mission is to develop innovative medical device laser solutions that make the world a better place. To accomplish this mission, we are committed to attracting and retaining the best talent and an engaged and thriving workforce that drives a sustainable future for our company and society.\n\nThe Clinical Affairs Manager will report to the Director of Research at IPG Medical and will be responsible for leading and coordinating clinical aspects of R&D projects. Ability to work independently is a must. Highly developed organizational and resource-planning skills are required. This position is also responsible for assisting other departments (marketing, engineering, regulatory, QA) in investigating, verifying, optimizing, and validating prospective technologies from the clinical applications viewpoint.\n\nDuties\n• Conceives, plans, and executes clinical studies and tests of IPG Medical products, both existing and prospective\n• Develops statistical and numerical approaches to optimize development of new products and technologies\n• Leads clinical project teams and ensures timely and within-the-budget execution of project phases\n• Works closely with clinical and pre-clinical partners in health-care, academia and industry\n• Evaluates prospective areas of research and avenues of product development, makes timely and relevant recommendations to the management of IPG Medical\n• Writes scientific publications and presents papers at scientific/industrial conferences\n• Develops, maintains, and leverages thorough working knowledge of the company's current products\n• Generates relevant IP and contributes to other publications (e.g., marketing)\n• Interacts with other groups and departments of the company, both providing necessary assistanc","datePosted":"4 days ago","hiringOrganization":{"@type":"Organization","name":"IPG Photonics","sameAs":"https://www.ipgphotonics.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Marlborough","addressRegion":"Massachusetts","addressCountry":"US"}},"employmentType":"PART-TIME","directApply":true},{"@context":"https://schema.org","@type":"JobPosting","title":"Design Quality Engineer II- Actalent Services, LLC","description":"Design Quality Engineer II\n\nLocation: Irvine, CA\n\nPay Rate: $55-$65/hr ($115,000-$130,000)\n\nIndustry: Global Medical Technology & Innovation\n\nAbout Us\n\nJoin a world-class leader in medical technology that is transforming healthcare through innovation and precision engineering. Their mission is simple yet powerful: to improve patient outcomes and empower healthcare professionals with cutting-edge solutions. They thrive on collaboration, integrity, and a relentless commitment to quality. There, your work will directly impact lives around the globe.\n\nThe Role\n\nAs a Design Quality Engineer II, you will play a pivotal role in ensuring the quality and compliance of new medical device products throughout their development lifecycle. You’ll support design control processes, lead risk management activities, and participate in design reviews to guarantee product excellence and adherence to global regulatory standards.\n\nWhat You’ll Do\n• Develop quality assurance documentation for new product development and regulatory submissions.\n• Maintain and improve quality system processes by identifying and correcting deficiencies.\n• Engage in design, development, manufacturing, and risk management activities for new projects.\n• Participate in design reviews, identify product risks, and ensure effective mitigation strategies.\n• Define and validate design verification and validation test requirements.\n• Complete final design verification and validation reports with statistical and graphical support.\n• Promote efficient testing practices and support manufacturing process development.\n• Utilize statistical analysis and problem-solving techniques to establish product acceptance limits.\n• Review and approve inspection plans, routers, and product drawings for new products.\n• Support product design transfers to manufacturing facilities.\n• Lead risk management activities, including developing risk management plans and conducting reviews.\n\nWhat We’re Looking For\n• Experience with medical device product development lifecycle, including risk management and design/process verification and validation.\n• Applied knowledge of advanced quality tools (FMEA, GD&T, Root Cause Analysis, Mistake Proofing).\n• Ability to read and interpret CAD drawings.\n• Experience interacting with regulatory agencies (FDA, MoH, TUV).\n• Thorough knowledge of US and international medical device regulations.\n• Strong understanding of quality concepts (CAPA, audits, statistics).\n• Excellent project management, communication, and problem-solving skills.\n• Proficiency with analysis programs like MiniTab.\n\nWhy You’ll Love It Here\n• Work on life-changing technologies that make a real difference in healthcare.\n• Collaborate in a dynamic, cross-functional environment focused on innovation and quality.\n• Enjoy competitive benefits, including 2 weeks PTO and 10 paid holidays.\n• Be part of a culture that values diversity, inclusion, and professional growth.\n\nReady to make an impact in healthcare? Apply now and help us shape the future of medical technology.\nJob Type & Location\n\nThis is a Contract position based out of Irvine, CA.\nPay and Benefits\n\nThe pay range for this position is $55.00 - $65.00/hr.\n\nEligibility requirements apply to some benefits and may depend on your job\nclassification and length of employment. Benefits are subject to change and may be\nsubject to specific elections, plan, or program terms. If eligible, the benefits\navailable for this temporary role may include the following:\n\n• Medical, dental & vision\n• Critical Illness, Accident, and Hospital\n• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available\n• Life Insurance (Voluntary Life & AD&D for the employee and dependents)\n• Short and long-term disability\n• Health Spending Account (HSA)\n• Transportation benefits\n• Employee Assistance Program\n• Time Off/Leave (PTO, Vacation or Sick Leave)\nWorkplace Type\n\nThis is a fully onsite position in Irvine,CA.\nApplication Deadline\n\nThis position is anticipated to close on Dec 23, 2025.\nAbout Actalent\n\nActalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.\n\nThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.\n\nIf you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.","datePosted":"4 days ago","hiringOrganization":{"@type":"Organization","name":"Actalent","logo":"https://encrypted-tbn0.gstatic.com/images?q=tbn:ANd9GcSNoSxJxYbmxN-G4xrVO8ggcCMX6SQ5wNhxEPnb&s=0","sameAs":"https://www.actalentservices.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Irvine","addressRegion":"California","addressCountry":"US"}},"employmentType":"CONTRACTOR","directApply":true,"baseSalary":{"@type":"MonetaryAmount","currency":"USD","value":{"@type":"QuantitativeValue","minValue":55,"maxValue":65,"unitText":"HOUR"}}},{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Engineer - Medical Devices","description":"Salary: Minimum of $70,000\n\nQuality Engineer- Medical Devices\n\nReports To: Quality Assurance Manager\n\nDepartment: Quality\n\nDivision: Northern Division\n\nLocation: Headquarters\n\nSummary:\nProvides quality engineering support during new business development, program launches, and for existing customers. The Quality Engineer will ensure that manufacturing processes, quality systems, and finished products for medical devices meet all applicable regulatory, customer, and internal quality requirements.\n• This role involves working in anITAR-controlled environment. The successful candidate will have a strong technical background, problem-solving skills, and the ability to work within the strict compliance requirements of ITAR regulations.\n\nEssential Duties and Responsibilities:\n• Support new business development\n• Provides support to new business development relating to quality matters as needed.\n• Draft preliminary Quality Plan, if appropriate.\n• Provides cost and time estimates for anticipated quality department services such as metrology or validation services.\n• Functions as a resource for CFR Part 820 and ISO 13485 regulatory requirements.\n• Support Program Launch and Product Realization as functional department representative assigned to team and Program Manager\n• Reviews new program drawings/information/customer specifications to understand program requirements.\n• Support customer audits, regulatory inspections, and certification.\n• Drafts program Quality Plan, PFMEA, and Dynamic Control Plans as required.\n• Drafts other required quality documentation such as Dimensional Visual Quality Requirements (DVQRs) and new product inspection techniques.\n• Confirms customer agreement on GD&T callouts/interpretations and all critical dimensions of program when required.\n• Prepares manufacturing job travelers and associated process documents.\n• Develops required Control/Test methods.\n• Ensures First Article Inspection (FAI) and Capability Studies are scheduled and completed.\n• Completes FAI and capability study analysis for submission to customer.\n• Generates validation plans, operational qualification (OQ), performance qualification (PQ) protocols, and provides training for protocol participants.\n• Oversees the execution of assigned validation activities to ensure compliance with protocol requirements and completion of study tasks.\n• Generates Required validation completion reports to include resolution of any deviations recorded and overall study conclusion.\n• Perform first-piece and in-process approvals for new setups, tooling changes, or process adjustments.\n• Attends program team meetings to support production-related matters.\n• Performs assigned activities in a timely manner.\n• Provide continuous quality engineering support through program end of life.\n• Completes Certificates of Conformance (CoC) for outgoing products, where required.\n• Collects and analyzes production line data to monitor yield and defect performance.\n• Use statistical tools (SPC, DOE, capability studies) to identify process improvement opportunities.\n• Maintains Device Master Records including Device History Records as required.\n• Performs periodic risk assessments, as required.\n• Assists Purchasing Department with maintaining vendor quality requirements.\n• Continuously monitors production to identify quality-related customer issues and supports corrective action plans when necessary.\n• Issue or authorize customer complaints and returns as needed. Manages the return of goods, assignments and close out of RC/CA.\n• Documents nonconformances, conducts thorough root cause analyses, and develops and implements effective corrective action plans.\n• Manages product and process change control and notification to ensure required Engineering Change Orders (ECOs) are generated and approved by the customer prior to implementation.\n• Attends program team meetings as necessary to resolve program quality issues to maintain customer satisfaction.\n• Support quality business reviews with customer and provides/presents quality-related topics.\n• Participates in customer, certified body, and regulatory audits as a subject matter expert for assigned products and processes.\n\nHas a working knowledge of:\n• Statistical techniques and tools (Minitab) and sampling plans.\n• Strong analytical and root cause problem-solving skills (5-Whys, Fishbone, 8D).\n• Quality Systems Regulations and ISO Standards.\n• Advanced Product Quality Planning (APQP)\n• Multiple manufacturing processes (e.g., injection molding, machining, assembly, packaging).\n• Occasional domestic travel required.\n• Other duties as assigned.\n\nCompetency:\n\nTo perform the job successfully, an individual should demonstrate the following competencies:\n\nAnalytical - Collects and researches data; Uses intuition and experience to complement data.\n\nProblem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions.\n\nCustomer Service - Manages di","datePosted":"4 days ago","hiringOrganization":{"@type":"Organization","name":"Mack Molding","logo":"https://encrypted-tbn0.gstatic.com/images?q=tbn:ANd9GcRu-PWo1GMeAlf6wNJOdpOR6Lf64BZDXeX9SPES&s=0","sameAs":"https://www.mack.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Arlington","addressRegion":"Vermont","addressCountry":"US"}},"employmentType":"FULL-TIME","directApply":true}]

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