Product Certification Safety- Electrical Engineer

Product Certification Safety - Electrical Engineer

Location:

Lake Forest, CA

• Perform safety certification test assessments throughout the development lifecycle including early stages to provide necessary inputs to R&D to drive product development.
• Support development including planning, communicate periodic status and known risks (with proposed solutions) to R&D core teams.
• Capable of performing safety testing of Alcon products in the Alcon 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 are required (assessed during interview).
• Plan and execute safety testing of electrical equipment and certification for global market access.
• Ensure compliance with product safety testing requirements and procedures per the governing standards and Alcon QMS. Includes ensuring test samples meet production equivalency requirements.
• Use and ensure maintenance of commonly used safety equipment, and calibration procedures. Provide guidance and requirements to external labs used for certification testing.
• Working knowledge of ISO 14971 Risk Management for medical devices in medical device product safety compliance, and/or fully accredited test labs.
• Strong familiarity with EMC test planning and procedures per IEC 60601-1-2 and associated test practices.

$90,000.00 - $ per year (Full Time)

• 401(k)
• 401(k) matching
• Relocation bonus