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Design Controls Engineer
Job in
Avenel, Middlesex County, New Jersey, 07001, USA
Listed on 2026-03-03
Listing for:
Katalyst Healthcares & Life Sciences
Full Time
position Listed on 2026-03-03
Job specializations:
-
Engineering
Systems Engineer, Biomedical Engineer
Job Description & How to Apply Below
Job Description:
We are seeking an experienced Human Factors Design Controls Engineer to join a leading medical device organization. This role will collaborate closely with cross-functional teams to support usability engineering, design controls, and risk management activities for innovative medical technologies.
Responsibilities:
- Support usability engineering documentation and design controls.
- Remediate and improve risk analysis documentation per ISO 14971 & IEC 62366.
- Work cross-functionally with HF, Quality, Regulatory, Engineering & Clinical teams.
- Manage requirements, traceability & compliance using tools like Polariton, Agile, Smart sheets.
- Create structured usability deliverables for regulatory submissions.
- 5+ years in Human Factors / Design Controls / Risk Management.
- Medical device development experience required.
- Strong knowledge of ISO 13485, FDA Design Controls, ISO 14971, IEC 62366.
- Proficient with collaboration & documentation tools (Polariton / Agile / etc.).
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