Experience:

• safety testing: 3 years (Preferred)
• Leakage current testing: 3 years (Preferred)
• ISO 14971 Risk Management: 3 years (Preferred)
• safety compliance: 3 years (Preferred)
• EMC test planning and procedures: 3 years (Preferred

• Product Certification Safety- Electrical Engineer(501504)
• 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 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 is 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 products safety compliance, and/or fully accredited test labs.
• Strong familiarity with EMC test planning and procedures per IEC 60601-1-2 and associated test practice
  Job Type: Contract
  Pay: $45.00 - $48.00 per hour

Schedule:

• 8 hour shift

Experience:

• safety testing: 3 years (Preferred)
• Leakage current testing: 3 years (Preferred)
• ISO 14971 Risk Management: 3 years (Preferred)
• safety compliance: 3 years (Preferred)
• EMC test planning and procedures: 3 years (Preferred)

Ability to Commute:

• Lake Forest, CA 92610 (Preferred)

Work Location: In perso