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

Our client, located in South Orange County, is one of the largest medical device makers within the optical surgery space. They are urgently seeing a Laboratory Safety Engineer to work hands‑on in their Labs on new medical devices. They continue to grow their departments and add new engineers monthly.

This is a hybrid 4x a week onsite position, so they would need to be local to the South Orange County area.

• Minimum
  
  Education and Experience:
• BS + 3+ years in medical device products safety compliance, and/or fully accredited test labs such as UL, CSA, Intertek or Element, etc.
• Working knowledge of IEC 60601-1 3rdEd (3.1 and 3.2) of medical electrical equipment standards and including particulars & collateral standards.
• Proven experience in successfully being able to work with cross functional teams

• Perform Safety certification test assessments throughout the development lifecycle including early stages to provide the necessary inputs to R&D to drive product development.
• Support development including planning, communicate periodic status and known risks (with proposed solutions) on the projects to R&D core teams.
• Capable of performing safety testing and of their products in the safety Lab and external labs.
• Prepare documentation to execute safety certification activities – Isolation Diagrams, perform Dielectric and Leakage current testing, Construction evaluation using IEC generated test reports forms.
• Communicate with internal/external labs, technicians, and design engineers to accomplish timely/valuable results at optimal cost (from Quote request to final deliverables).
• Collaborate with teams to ensure full execution of identified required testing and review activities needed to ensure product compliance including de-risking product launches through pre-verification test rehearsals.
• Document and execute all V&V tests compliant to medical device QSR, ISO 13485. Prepare clearly written, accurate, highly detailed Safety verification test plans and test reports.
• Effectively communicate complex concepts in formal/informal presentations and in technical reports; proven technical writing skills is required (assessed during interview).
• 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 in medical device products safety compliance, and/or fully accredited test labs.
• DHF Artifact Integration
  -use by Clause Compliance Matrix (core + applicable collaterals/particulars).Risk Management File: hazard analyses, risk controls, verification links, residual risk evaluations, benefit risk.
  
  PEMS/Software safety case artifacts (requirements, architecture, verification).Design Inputs & DVP&R aligned to standards clauses.

• 60-90/hr pay rate DOE
• W2 Employee Benefits
• potential for full-time offer after the contract is over.
• optional 401k