Device Engineer / Scientist - Design Verification & Medical Devices (MDR/FDA) | ???? Device Engineer / Scientist (m/w/d) Design Verification & Medical Devices (MDR/FDA)
expertum GmbH
Job Summary
This role is for a Device Engineer/Scientist focused on the design verification and development of medical and combination products within a pharmaceutical industry setting. You will be responsible for planning, executing, and coordinating design verification activities, creating verification plans, test strategies, and regulatory reports. A key aspect of the job involves ensuring compliance with regulatory requirements such as MDR, FDA, and Design Control (21 CFR 820.30), and integrating these into development processes. You will also act as an Evaluation Engineer within interdisciplinary teams, coordinating work packages and collaborating closely with Design Engineering, Quality Assurance, Risk Management, and Usability Engineering. The position requires a degree in a life sciences discipline and several years of professional experience in regulated medical product development.
Required Skills
Education
Completed degree in a life sciences discipline (e.g., Medical Technology, Biotechnology, Pharmacy, Engineering, Natural Sciences)
Experience
- Several years of professional experience in the regulated development environment of medical or combination products
- Professional experience in planning, execution, and documentation of design verifications
- Professional experience in Design Control processes (e.g., according to 21 CFR 820.30 or MDR)
- Professional experience working in interdisciplinary development teams
- Professional experience in collaborating with Quality Assurance, Risk Management, and Usability Engineering
Languages
Additional
- Not specified
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