Product Certification Safety- Electrical Engineer
Apply NowCompany: United IT Solutions, Inc.
Location: Lake Forest, CA 92630
Description:
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
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