Medical Device Engineer
Job Summary
Supporting analyses of medical device degradation, the full-time salaried Medical Device Engineer or Materials Scientist will provide scientific and technical consultation related to regulatory reviews and product development for implantable medical devices, working 100% remotely.
Key responsibilities
- Support analyses of medical device degradation in relation to regulatory and technical aspects
- Provide consultation for medical device reviews including EUA, 510(k), PMA, and related submissions
- Develop written reviews, correspondence, and detailed reports
Required qualifications
- Advanced degree (MS, PhD) in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Materials Science, or equivalent
- Demonstrable expertise in degradation (fretting, wear, corrosion) of implantable medical devices
- Experience with mechanical and chemical performance testing of orthopedic and cardiovascular implants
- 10 years of experience in medical device engineering and/or materials science
- Experience supporting FDA 510(k) and related regulatory submissions
Complete Job Description
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