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Product Certification Safety- Electrical Engineer at Lake Forest, CA

DBSI Services
Forest, CA Full Time
POSTED ON 2/18/2025
AVAILABLE BEFORE 5/13/2025

Job Description

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 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 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 practices.

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