Product Certification Safety- Electrical Engineer

Role : Product Certification Safety- Electrical Engineer

Work Location : Lake Forest, CA (Onsite)

Must Have Skills : Electrical Engineer with medical device products safety compliance, IEC 60601-1, EMC / EMM, V&V tests compliant to medical device

JD :

• 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