- Insulet Corporation (Acton, MA)
- …a cGMP compliant environment and operate within FDA guidelines for Class II Medical Device manufacturing. Author and implement Engineering Change Orders Up to ... Engineering and 6+ years of manufacturing experience; preferably in medical device MS. in Mechanical/Industrial/Electrical or Engineering Management… more
- Actalent (New Town, MA)
- …for complex electro-mechanical medical devices and disposables within a regulated medical device development environment. Responsibilities Act as a key team ... Job Title: Fixture Design Engineer Job Description The Senior Manufacturing Fixture Design...in the design, qualification, and verification of fixtures for medical device assembly and testing. Expertise in… more
- Katalyst HealthCares and Life Sciences (Boston, MA)
- …bachelor's degree or higher in Mechanical engineering. 5+ years of experience in medical device manufacturing engineering, including at least three years in new ... and optimized efficient, cost-effective, and validated manufacturing processes for medical devices, focusing on capital and/or disposable devices, including… more
- Michael Page (Northborough, MA)
- Cutting-Edge Medical Device Innovation Opportunities for Growth and Skill Development About Our Client My client is a leader in the manufacturing of catheters ... within medical device manufacturing. The company provides cutting-edge...place to build a career. Job Description Product Development Quality Engineer : Ensure Design Compliance: Oversee product… more
- Katalyst HealthCares and Life Sciences (Andover, MA)
- …(21 CFR Part 820.30, ANSI HE75). Proven leadership in human factors for medical device development. Skilled communicator and collaborator across disciplines. ... Marketing teams. Responsibilities: Lead formative and summative usability studies for medical devices. Develop detailed usability and risk analysis reports (IEC… more
- Cytiva (Shrewsbury, MA)
- …a plus if you also possess previous experience in: Experience in the Bio-Science, Medical Device , or Pharma industries. Ability to read and understand electrical ... Business System which makes everything possible. The Automation Manufacturing Engineer resolves daily operational challenges, engages in strategic initiatives, and… more
- Katalyst HealthCares and Life Sciences (Walpole, MA)
- …Quality Engineering or similar role within an FDA regulated industry preferably medical device and diagnostics that includes experience with CAPA and auditing ... processes. The Design Quality Engineer will participate in the governance, and execution of the Quality Management sub-system element of Design Change.… more
- Mondo Staffing (Danvers, MA)
- …engineering. Strong experience with submission documentation and risk management. Prior work in medical device quality for disposables or capital equipment. ... Apply now: Design Quality Engineer , Remote (Ideally Local). The...June) Compensation Range: $55-$63/hour W2 Job Description: Support design quality initiatives for medical device … more
- Philips (Cambridge, MA)
- **R&D Application Software Engineer - C++ & Python for Medical Device (Cambridge, MA)** Join the Breakthrough Innovation Teams (BRITE) at Philips to build ... (proficiency in C++ and Python are required). Experience in medical device is required. + You have...won't stop until everybody, everywhere, has access to the quality of healthcare that we all deserve. Do the… more
- Medtronic (Newton, MA)
- …intuitive, user-friendly interfaces that enhance the usability and functionality of our advanced medical devices. The Senior Software Engineer will be a key ... culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role requires candidates to be local to the… more
- Medtronic (Billerica, MA)
- …and writing in English. **Preferred Qualifications (Must Have!):** + Prior experience in the medical device or electronics industry. + Knowledge of ISO and FDA ... Billerica site. This role is critical to ensuring the quality and precision of our products. The ideal candidate...up to 6% match + Comprehensive benefits plan, including medical , dental, vision, and more + Fully subsidized Bachelors… more
- ManpowerGroup (Westford, MA)
- Our client, a leader in the medical device industry, is seeking a Quality Engineer to join their team. As a Quality Engineer , you will be part of ... which will align successfully in the organization. **Job Title:** Engineer , Quality **Location:** Westford, MA **Pay Range:**...**Pay Range:** **What's the Job?** + Initiate and oversee medical device quality assurance activities… more
- Philips (Cambridge, MA)
- …of 3+ years' experience of Quality Engineering experience within FDA regulated, medical device product environments, with a focus in Design Quality ... The Quality Engineer -Products and Systems is a...working knowledge of Risk Management (ISO 14971) and global medical device product regulations, requirements and standards.… more
- Teleflex (Chelmsford, MA)
- Quality Engineer 2, Design Assurance PMS **Date:** Jul 8, 2025 **Location:** Chelmsford, MA, US **Company:** Teleflex **Expected Travel** : Up to 10% ... Summary** As a member of a cross-functional team, the Quality Engineer II, Design Assurance is responsible... engineering or design assurance experience (preferably in the medical device industry). **Specialized Skills / Other… more
- Abbott (Burlington, MA)
- …of FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (eg, 62304), EU Medical Device Regulations and MDSAP + Experience with medical ... their lives. We are seeking an experienced **_Staff Software Quality Engineer_** to ensure our medical devices...**_Staff Software Quality Engineer_** to ensure our medical devices are developed in accordance with Abbott's design… more
- Amazon (North Reading, MA)
- Description MULTIPLE POSITIONS AVAILABLE Employer: AMAZON.COM SERVICES LLC Offered Position: Quality Assurance Engineer II Job Location: North Reading, ... and automated tests for complex systems, and test mobile device development kits and device frame works....experience in the job offered, or as a Programmer/Analyst, Quality Assurance Engineer , Software Test Developer, or… more
- Medtronic (Boston, MA)
- …world. **A Day in the Life** A Day in the Life of a Principal Quality Engineer , Post-Market Risk Responsibilities may include the following and other duties may ... SKILLS OR EXPERIENCE * Risk Management experience in the medical device industry * Risk Management File...tools and techniques * Significant breadth and depth in quality decision making, risk management, quality engineering,… more
- Sanofi Group (Cambridge, MA)
- …or similar - required. + **Professional working experience 7+ years in medical device or combination product development, industrialization or manufacturing - ... device design and successful delivery of Drug Device Combination Products and Medical Devices. Working...collaborating closely with cross-functional teams and interacting with Global Device / Quality Leadership Teams and other… more
- Hologic (Marlborough, MA)
- …quality systems and change management. **Essential Duties and Responsibilities:** + ** Medical Device Quality Assurance:** Provide comprehensive support to ... System Regulation, especially Design Control requirements, ISO 13485 Medical Device Quality management System,...adaptability + Bilingual is a plus + ASQ Certified Quality Engineer and Six Sigma Certification are… 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 ... development team on new product development or on design changes to ensure product quality and minimize risk to users and patients as well as regulatory and… more
