Ecocareers ยท 2 months ago
Design Controls Engineer
United States
Full-time
Remote
Senior Level
5+ years expEcocareers is a leading medical device organization, and they are seeking an experienced Human Factors Design Controls Engineer. This role will collaborate closely with cross-functional teams to support usability engineering, design controls, and risk management activities for innovative medical technologies.
Staffing & Recruiting
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
Qualification
Required
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.)
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase