Product Safety Engineer / Lab Setting / Irvine, CA

Our client, based in South Orange County, is one of the leading medical device manufacturers in the optical surgery industry. They are urgently seeking a Laboratory Safety Engineer to work hands-on with their medical devices in the lab. The company continues to expand, adding new engineers to their teams each month.

This role is hybrid with four days onsite per week, so candidates must be local to the South Orange County area.

Required Qualifications

• Education & Experience:

  • BS degree with 3+ years of experience in medical device product safety compliance and/or experience with fully accredited test labs (UL, CSA, Intertek, Element, etc.)

• Strong working knowledge of IEC 60601-1 3rd Edition (3.1 and 3.2) medical electrical equipment standards, including collateral and particular standards.

• Demonstrated ability to work effectively with cross-functional teams.

Responsibilities

• Conduct safety certification test assessments throughout the product development lifecycle, including early-stage reviews to provide critical input to R&D.

• Support development activities by planning, communicating status updates, and identifying risks with proposed solutions to R&D core teams.

• Perform safety testing on company products both in the internal safety lab and at external labs.

• Prepare documentation for safety certification activities, including isolation diagrams, dielectric and leakage current testing, and construction evaluations using IEC test report forms.

• Coordinate with internal and external labs, technicians, and design engineers to ensure timely, cost-effective testing from quote requests through final deliverables.

• Collaborate cross-functionally to ensure all required safety testing and review activities are executed, including pre-verification test rehearsals to mitigate risks ahead of product launches.

• Document and execute all V&V tests in compliance with medical device QSR and ISO 13485. Prepare detailed, accurate safety verification test plans and reports.

• Communicate complex technical concepts clearly in presentations and reports; strong technical writing skills are required.

• Experience with global electrical equipment safety testing and certification.

• Experience with product safety testing procedures and requirements.

• Experience using and maintaining common safety equipment and performing calibration procedures.

• Working knowledge of ISO 14971 Risk Management for Medical Devices.

Compensation & Benefits

• $65–$70/hr (DOE)

• W2 employment with benefits

• Potential for a full-time offer upon completion of the contract

• Optional 401(k)