Design Controls Engineer
Job in
Montclair, Essex County, New Jersey, 07043, USA
Listed on 2026-05-30
Listing for:
Katalyst HealthCares & Life Sciences
Full Time
position Listed on 2026-05-30
Job specializations:
-
Engineering
Systems Engineer, Biomedical Engineer, Engineering Design & Technologists
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 & IEC.
- 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.
- + years in Human Factors / Design Controls / Risk Management.
- Medical device development experience required.
Strong knowledge of ISO , FDA Design Controls, ISO , IEC. - Proficient with collaboration & documentation tools (Polariton / Agile / etc.).
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