Medical Device Project Manager
About The Position
We are seeking a skilled Medical Device Project Manager with strong hands-on experience in U.S. medical device product development. The ideal candidate will possess a deep understanding of the engineering development lifecycle, from concept to commercial launch, and have solid knowledge of regulatory requirements including FDA processes, QMSR, ISO 13485, and design controls. Familiarity with risk analysis, verification setups, and regulatory documentation is essential. Experience working with Contract Manufacturers (CMs) is also required. This role demands excellent engineering communication, planning, and cross-functional coordination skills.
Requirements
- Strong hands-on experience in U.S. medical device product development.
- Deep understanding of the engineering development lifecycle from concept to commercial launch.
- Solid knowledge of FDA processes, QMSR, ISO 13485, and design controls.
- Familiarity with risk analysis, verification setups, and regulatory documentation.
- Experience working with Contract Manufacturers (CMs).
- Excellent engineering communication skills.
- Excellent planning skills.
- Excellent cross-functional coordination skills.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
