Senior Design Engineer
Job in
Newton, Middlesex County, Massachusetts, 02165, USA
Listed on 2026-02-28
Listing for:
Cube Hub Inc.
Full Time, Seasonal/Temporary
position Listed on 2026-02-28
Job specializations:
-
Engineering
Biomedical Engineer, Quality Engineering, Medical Device Industry, Electrical Engineering
Job Description & How to Apply Below
Job Title:
Senior Design Quality Engineer (Contract)
Location:
Newton, MA Duration: 12+ Months (Contract/Temp with the possibility of extension) Shift: 1st Shift (9:00 AM to 5:00 PM) Job Description
We are seeking a Senior Design Quality Engineer (Contractor) to support development of complex, high‑risk medical device systems. This role will lead Design Controls and serve as the Quality representative on cross‑functional product development teams.
Key Responsibilities- Lead Design Control activities per FDA 21 CFR 820.30 and ISO 13485
- Own risk management activities per ISO 14971 (FMEA, SWFMEA)
- Review and approve Verification & Validation (V&V) protocols and reports
- Support HW/SW integration and software compliance (IEC 62304/82304)
- Support electrical safety and EMC compliance (IEC 60601 series)
- Contribute to IDE, De Novo, and/or PMA submission documentation
- Lead/support CAPA, complaint investigations, and NCMR activities
- Bachelor’s degree in Engineering or related field
- 7–10 years in medical device industry
- Experience with Class III electro‑mechanical devices
- Strong knowledge of FDA QSR, ISO 13485, ISO 14971
- Experience with medical device software compliance
- Applied statistics experience (Minitab or similar)
- Strong documentation and communication skills
- Experience supporting De Novo or PMA submissions
- Experience with robotic or image‑guided systems
Position Requirements
10+ Years
work experience
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