Product Certification Safety- Ee Engineer

Location: Lake Forest, CA
Salary: $60.00 USD Hourly - $80.00 USD Hourly
Description: Our client seeking a Medical Device Safety Compliance Specialist to join their team onsite at the Lake Forest location. The ideal candidate will possess expertise in the IEC 60601-1 series of standards, including applicable test methods on medical devices, and have experience working within an accredited safety agency such as UL, TUV SUD, Intertek, CSA, etc.

This job will have the following responsibilities:

• Perform safety certification test assessments throughout the development lifecycle, including early stages, to provide necessary inputs to R&D to drive product development.
• Support development by planning, communicating periodic status, and identifying known risks (with proposed solutions) on projects to R&D core teams.
• Perform safety testing of Alcon products in the Alcon safety lab and external labs.
• Prepare documentation to execute safety certification activities, including Isolation Diagrams, Dielectric and Leakage current testing, and Construction evaluation using IEC-generated test report forms.
• Communicate with internal/external labs, technicians, and design engineers to achieve timely and valuable results at optimal cost (from quote request to final deliverables).
• Collaborate with teams to ensure full execution of 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 with medical device QSR and ISO 13485. Prepare clearly written, accurate, and highly detailed safety verification test plans and test reports.
• Effectively communicate complex concepts in formal/informal presentations and technical reports; proven technical writing skills are required (assessed during the 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 governing standards and Alcon QMS, including 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 product 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.

Qualifications & Requirements:

• Expert knowledge of IEC 60601-1 3rd Ed (3.1 and 3.2) of medical electrical equipment standards, including particulars and collateral standards.
• Proven experience in applying these standards to EM medical devices.
• Bachelor's degree in Electrical Engineering (EE) or a similar major preferred.
• 4 years of experience in medical device product safety compliance evaluations and/or fully accredited test labs such as UL, CSA, Intertek, or Element.

Contact:

This job and many more are available through The Judge Group. Please apply with us today!

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