- Sanofi Group (Cambridge, MA)
- …this role, you'll be at the forefront of innovation, combining your expertise in medical device patents with advanced AI-driven patent tools. You'll work closely ... to get started? **Main responsibilities:** + Draft and prosecute high- quality patent applications for medical devices and...Stay abreast of the evolving legal landscape related to medical device IP and AI in patent… more
- Terumo Medical Corporation (Boston, MA)
- …Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications ... drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of...of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in… more
- Hologic (Marlborough, MA)
- …department in our Diagnostics division is looking for a Security Engineer experienced in medical device and/or instruments security and systems to join our team, ... representative ensuring that our products are meeting industry standards and FDA requirements throughout the product lifecycle, including post-market. This is a… more
- Olympus Corporation of the Americas (Westborough, MA)
- …product security, cybersecurity, and equipment development oversight. Extensive knowledge of medical device design control requirements, system design and ... and design for manufacturability and testability is required. Deep understanding of medical device standards, and experience in their application, is required.… more
- Catalent Pharma Solutions (Chelsea, MA)
- **Manager, Quality Control (Clinical and Tech Transfer Team)** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing ... its kind for DPI in North America. Catalent Pharma Solutions is hiring a Manager, Quality Control (QC) who is a key analytical leader in the Clinical and Tech… more
- Takeda Pharmaceuticals (Lexington, MA)
- …+ Support the optimization of design control elements to comply with combination produce/ medical device regulations. Lead or assist in deviation, complaint and ... and 7+ years preferably within the biopharmaceutical industry or medical device development and commercialization are desired.... device design control process evolution to meet device regulations. + Collaborate with Quality , Mfg,… more
- Fresenius Medical Center (Lawrence, MA)
- …alignment across the organization. + Provide planning and project management support for medical device product launches. + Assist in the development and ... applying human factors engineering principles to optimize usability, cost, quality , safety, and performance. Specific duties include: + Represent...years of experience as a Product Manager in a medical device field or (ii) Master's degree… more
- Candela Corporation (Marlborough, MA)
- …that meets internal quality requirements and regulatory standards for Class I/II medical devices ( FDA 21 DFR 820.30, ISO 14791, IEC 62304, IEC 62366) ... **Massachusetts** **Company Overview:** Candela Corporation is a leading global aesthetic device company with a comprehensive product portfolio and a global… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …in applying FDA design control requirements (21 CFR ) as applied to medical device software and medical device regulation (IEC-62304) ... commitment to collaborative problem solving, sophisticated design, and the creation of quality products are essential. Your team's primary focus is building core… more
- Philips (Cambridge, MA)
- …the right fit if:** + You've acquired 5+ years of experience in the medical device regulatory affairs and/or quality assurance field. Experience authoring ... Tech Files required. + Your skills include knowledge of quality system requirements and FDA and/or International...include knowledge of quality system requirements and FDA and/or International product approval process, demonstrate a track… more