- Olympus Corporation of the Americas (Westborough, MA)
- …matter expertise, technical guidance, and leadership for the application of health and medical device SW regulatory standards to the Olympus SDLC, including IEC ... on regulations around health software development, and software for medical devices . + Collaborate on the update...+ Minimum of 6 years of experience in a medical device setting. + Experience in the… more
- Medtronic (Boston, MA)
- …plays a critical role in ensuring the security of Medtronic Surgical Operating Unit medical device solutions. Reporting to the Director of Product Security, this ... and digital solutions. This role focuses on cybersecurity for medical devices and embedded systems. It is...impact by exploring a career with the world's leading Medical Device company, striving "to alleviate pain,… more
- Medtronic (Danvers, MA)
- …with these will be prioritized):** + Experience in as a technician in medical device manufacturing. + Experience in injection molding operations, including ... in manufacturing operations, troubleshooting, and process optimization to ensure high- quality production. The ideal candidate will have extensive experience in… more
- Hologic (Marlborough, MA)
- …As a **Senior Post Market Quality Engineer ** , you will lead quality engineering efforts for on-market medical devices . This role is responsible for ... Senior Post Market Quality Engineer Newark, DE, United States... System Regulations (especially Design Control), ISO 13485, EU Medical Device Regulation, ISO 14971, Risk Management,… more
- Actalent (Waltham, MA)
- Job Title: Software Quality Engineer II Job Description We are seeking a dedicated Software Quality Engineer II to join our dynamic team in a hybrid work ... skills. Additional Skills & Qualifications + Experience in the medical device domain is preferred. + Working...Familiarity with ISO and FDA documentation and compliance for medical devices . Job Type & Location This… more
- Fresenius Medical Center (Lawrence, MA)
- **PURPOSE AND SCOPE** Act as a Quality Business Partner for Software as a Medical Device and Non- medical software device engineering teams to ensure ... product development or on design changes to ensure product quality and minimize risk to users and patients as...Overview: This position offers a comprehensive benefits package including medical , dental, and vision insurance, a 401(k) with company… more
- Medtronic (Newton, MA)
- …together to engineer the extraordinary. Join Medtronic as a **Senior** **Software Quality Engineer ** and be at the forefront of transforming lives through ... a team of engineers and cross-functional partners to drive quality for design, development, and maintenance of software for...written and oral communication skills. + 2+ years of medical device or other regulated industry (such… more
- Hologic (Marlborough, MA)
- …In-depth understanding of FDA Quality System Regulations, ISO 13485, and Medical Device Directive. + Expertise in compliance issues and regulatory ... Principal Quality Assurance Engineer Marlborough, MA, United...+ Minimum 12+ years in the medical device industry. + Proven track record in quality… more
- Integra LifeSciences (Mansfield, MA)
- …industry with knowledge of Risk Management (ISO 14971 2019), MDD ( Medical Device Directive), IEC 62366, ISO 13485 ( Quality Management Systems), FDA QSR and ... standards of care. This **Staff Design & Reliability Assurance Quality Engineer ** is a key functional role...DFSS techniques * 8 years of experience in a Quality Assurance role for medical device… more
- Fresenius Medical Center (Lexington, MA)
- …executing, and championing research and development activities of Fresenius' medical devices . Will be involved in quality planning, internal audits, data ... Engineer (Product Development), NxStage Medical , Inc., a...modalities to the design of a medical device ; + Designing test methods for devices or… more