- 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) ... + Own and deliver software architecture, diagrams, design documents + Primary engineering lead, directing a team of Cloud/backend developers in the delivery of… more
- Philips (Cambridge, MA)
- …Regulations (ISO 9001, ISO 13485, 21 CFR Part 803, 806 & 820) and knowledge of medical device process requirements + You have a minimum of a Bachelor's ... of Quality Engineering experience within FDA regulated, medical device product environments, with a focus...1990, applicants that require accommodation in the job application process may contact ###, option 5, for assistance. Equal… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …years of experience as an engineer developing products, preferably in the medical device industry required + Project Management Professional (PMP) certification ... that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide...technical in nature and the applicant must have an engineering background in order to manage and contribute to… more
- ConvaTec (Lexington, MA)
- Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the ... of Convatec's Applied Research organization within the User Insights, Design, & Engineering Solutions team, the R&D Associate supports the development of advanced… more
- Teradyne (North Reading, MA)
- …powering next-generation technologies through sophisticated solutions. Behind every electronic device you use, Teradyne's test technology ensures your device ... communities, thrive. Our Purpose The Teradyne Semiconductor Test Embedded Firmware Engineering team is looking for a highly-motivated, energetic, technically driven… more
- Olympus Corporation of the Americas (Westborough, MA)
- …materials. + Responsible for development, coordination, preparation and maintenance of US medical device submissions such as Pre-Submissions, 510(k)s, PMAs, IDEs ... as needed. + Where designated, responsible for development, coordination, preparation and maintenance of medical device submissions for Canadian Class 2, 3 or 4 … more
- RTX Corporation (Andover, MA)
- …+ Frequently work on the foundry floor and interact with various process engineering , equipment engineering , digital technologies, quality, facilities, ... member of the AMS Department, the individual in this role will serve as a process improvement engineering lead and collaborate with the various engineering … more
- Philips (Cambridge, MA)
- …a minimum of 7+ years' experience in Post Market Quality within FDA regulated medical device environments, with a focus on Complaint Handling and Vigilance ... in customer relations within the team. + You have detailed knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts… more
- Philips (Cambridge, MA)
- …strategy and execution to drive continuous quality improvements in the design of Medical Device products and systems to world-class levels, in close, ... quality-in-design tools, technologies, processes and techniques, with a specific focus on medical device -product/systems design to arrive at first time right,… more
- Teradyne (North Reading, MA)
- …development process by providing customer perspective to the design process * Assist cross-functional engineering teams in debugging discovered product ... powering next-generation technologies through sophisticated solutions. Behind every electronic device you use, Teradyne's test technology ensures your device… more