Product Certification Safety- Electrical Engineer
Product Certification Safety- Electrical Engineer
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1 Vacancy
Job Description
Job Title: Product Certification Safety Electrical Engineer
Location: Lake Forest CA
Job Description:
- 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 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 derisking product launches through preverification 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 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 IECand associated test practices.
Employment Type
Full Time
