Design Quality Engineer
Job in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2026-03-08
Listing for:
BioTalent
Full Time
position Listed on 2026-03-08
Job specializations:
-
Engineering
Biomedical Engineer, Quality Engineering, Medical Device Industry, Product Engineer
Job Description & How to Apply Below
Design Quality Engineer – Medical Device
A fast‑growing medical device company is seeking a Design Quality Engineer to support new product development, product updates, and risk‑based engineering activities. This role partners closely with R&D, Engineering, Quality, and Regulatory to ensure products meet global safety and compliance standards.
What You’ll Do:- Lead Design Controls for new and existing products
- Support V&V planning, execution, and documentation
- Maintain risk management files (ISO 14971) and FMEAs
- Review and approve design documentation, specifications, and test reports
- Participate in design reviews and ensure alignment with FDA & ISO 13485 requirements
- Assist with design transfer, CAPAs, and audit support
- Engineering degree (Mechanical, Biomedical, Electrical, etc.)
- 3–5+ years in medical device design quality or R&D
- Strong knowledge of Design Controls, 21 CFR 820, and ISO 13485
- Experience with V&V, risk management, and cross‑functional collaboration
- High visibility with strong cross‑functional impact
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