- 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
- Amgen (Cambridge, MA)
- …automate model creation and post/processing. + Experience with combination products and device regulatory requirements, medical device development and design ... the lives of patients while transforming your career. Senior Engineer - Modelling and Simulation **What you will do**...to create models capturing the inherent variability in the process and device dimensions. + Skilled in… more
- Fresenius Medical Center (Lawrence, MA)
- …geometric tolerance analysis, and documentation is preferred + Strong understanding of medical device development processes + Able to communicate effectively, ... PURPOSE AND SCOPE: The Mechanical Engineer II will play a key role in...and/or testing of complex electro-mechanical products preferred + Prior medical device experience strongly preferred EO/AA Employer:… more
- Capgemini (Burlington, MA)
- …verification strategies, manage a team of engineers, and ensure compliance with medical device regulations. **Your Role** . Lead Verification Strategy: Develop ... systems. . Compliance & Standards: Ensure all verification activities align with relevant medical device regulations such as ISO 13485, IEC 62304, and FDA… more
- Philips (Cambridge, MA)
- …if:** + You have a minimum of 5+ years' experience within FDA regulated medical device Quality environments, with a focus on CAPA reviews, investigations, root ... The Senior Quality Engineer -CAPA will play a critical role within Philips'...opportunities for improvement. + You have detailed knowledge of medical device regulations, requirements, and standards, such… more
- Teleflex (Chelmsford, MA)
- …5 years of quality engineering or design assurance experience (preferably in the medical device industry). **Specialized Skills / Other Requirements** * ASQ ... Quality Engineer 2, Design Assurance PMS **Date:** Aug 6,...:12410 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …expertise in applying FDA design control requirements (21 CFR ) as applied to medical device software and medical device regulation (IEC-62304) ... **Job Description** We're looking for a Principal Software Engineer to join our growing team and lead...CI/CD for AWS serverless deployments + PHI/PII and/or Med device or other device -related experience + Demonstrated… more
- Philips (Cambridge, MA)
- The Quality Engineer -Products and Systems is a key member of our...CFR Part 803, 806 & 820) and knowledge of medical device process requirements + You ... of 3+ years' experience of Quality Engineering experience within FDA regulated, medical device product environments, with a focus in Design Quality/Control,… more
- Amazon (North Reading, MA)
- …to automate and simplify. This position will report to the Software Manager for Device Management - Cloud Services within the Global Edge Compute Team and have ... to design, develop, and operate the next generation of device automation systems that allow for the provisioning and...a highly collaborative environment. As an Amazon Software Development Engineer , you will help tackle a diverse landscape of… more
- RTX Corporation (Andover, MA)
- …products, how they are modeled and designed to function within the process technology, and the fundamental device physics driving their performance. ... of performance and yield drivers. + Establishing the relationships between physical process /tool outputs and device /product performance and yield. + Teaming with… more