Role OverviewThe Development Engineer moves released designs from R&D into production, ensuring design outputs are complete, manufacturable, and verified as suitable for manufacturing.
What You Will Do
Key responsibilities include leading design transfer, confirming design outputs, coordinating handoffs, and supporting pilot and first production builds.
Why It Might Be a Fit
The ideal candidate will have 3–7 years of engineering experience in medical devices or a regulated industry, with a strong understanding of design controls and quality system requirements.
Requirements
- BS in Mechanical, Biomedical, Manufacturing, or a related engineering field
- 3–7 years of engineering experience in medical devices or another regulated industry
- Working knowledge of design controls and quality system requirements (ISO 13485, FDA QMSR)
- Experience with engineering drawings, GD&T, BOMs, and change control
- Familiarity with process or test method validation concepts
- Experience writing and executing verification or validation test protocols, and familiarity with requirements management and traceability
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