Product Safety Engineer Job at Wipro, Lake Forest, CA

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  • Wipro
  • Lake Forest, CA

Job Description

  • BS (preferably in EE or similar major) + 4 years in medical device products safety compliance evaluations, and/or fully accredited test labs such as UL, CSA, Intertek or Element, etc.
  • Expert knowledge of IEC 60601-1 3rd Ed (3.1 and 3.2) of medical electrical equipment standards and including particulars & collateral standards. Proven experience in application to EM medical devices.
  • Proven experience in successfully being able to work with cross functional teams
  • Core responsibilities:

    • 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 practices

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