Product Safety Engineer and test​/Medical Devices​/IEC​/Lake Forest

Product Safety Engineer – Medical Devices – IEC 60601-1 – Lake Forest

Location:

South Orange County, California (Lake Forest)

Employment type:

Contract

Seniority level:
Mid‑Senior Level

• BS degree and 3+ years of experience in medical device product safety compliance or work in fully accredited test labs such as UL, CSA, Intertek or Element.
• Working knowledge of IEC 60601‑1 3rd Edition (parts 3.1 and 3.2) and related collateral standards.
• Proven experience working with cross‑functional teams.

• Perform safety certification test assessments throughout the development lifecycle, including early stages to provide inputs to R&D for product development.
• Support development by planning, communicating periodic status and known risks (with proposed solutions) to R&D core teams.
• Perform safety testing of products in the safety lab and external labs.
• Prepare documentation for safety certification activities – isolation diagrams, dielectric and leakage current testing, construction evaluation using IEC‑generated test‑report forms.
• Communicate with internal and external labs, technicians, and design engineers to achieve timely and valuable results at optimal cost.
• Collaborate with teams to ensure full execution of required testing and review activities, de‑risking product launches through pre‑verification test rehearsals.
• Document and execute all V&V tests compliant with medical device QSR and ISO 13485; produce detailed safety verification test plans and reports.
• Effectively communicate complex concepts in formal and informal presentations and technical reports; proven technical‑writing skills are required.
• Experience with safety testing of electrical equipment and certification for global market access.
• Experience with product safety testing requirements and procedures.
• Experience with use and maintenance of commonly used safety equipment and calibration procedures.
• Working knowledge of ISO 14971 Risk Management for medical devices and/or accredited test labs.
• Experience with DHF artifact integration, clause compliance matrix, risk‑management file, PEMS/software safety‑case artifacts, and design input alignment to standards clauses.

• Pay rate: $60–$90 per hour, DOE.
• W2 employee benefits.
• Potential for full‑time offer after the contract ends.
• Optional 401(k).