Product Safety Engineer

Product Safety Engineer – Motion Recruitment

Join our client, a leading medical device maker in optical surgery located in South Orange County. They are urgently looking for a Laboratory Safety Engineer to work hands‑on in their labs on medical devices. The position is a 4‑day hybrid onsite role; candidates must be local to the South Orange County area or North San Diego.

• Minimum
  
  Education and Experience:
  
  BS + 4+ years in medical device product safety compliance, and/or accredited test labs such as UL, CSA, Intertek or Element.
• Working knowledge of IEC 60601‑1 3rd Ed (3.1 and 3.2) of medical electrical equipment standards and related collateral standards.
• Proven experience successfully working with cross‑functional teams.

• Collaborate cross‑functionally within R&D, Manufacturing, Global Regulatory Affairs, QA, suppliers, and product certification teams, and partner with accredited agencies and NRTL’s to execute work outlined.
• Monitor relevant standards, editions, amendments and market‑specific adoptions.
• Assess impacts to products and accessories, including DHF artifacts, during design/development. Drive updates to DHF artifacts—Risk Management File (ISO 14971), Usability File (IEC 62366‑1), PEMS/software lifecycle evidence (IEC 62304), labeling/IFU, and design inputs.
• Plan and execute characterization (testing, analyses, documentation and report creation) as designs mature through the NPD lifecycle. Provide quantitative test data and analyses linked to IEC 60601‑1 clauses, and coordinate prototype reviews.
• Serve as Safety SME for market submissions, assessing risk of non‑conformances and preparing responses to deficiencies.
• Advise proactively on design and manufacturing changes with compliance implications to enable evidence‑based design decisions.
• Meet timelines and deliver on activities in sync with product teams’ development plans.
• Provide services on a time‑and‑material basis as outlined by project leadership.

• Pay rate: $65–$90/hr (DOE)
• W2 employee benefits.
• Potential for full‑time offer after contract.

Posted By:
Kevin Morley.

Mid‑Senior level

Contract

Management and Manufacturing