Job Description
Product Certification Safety- Ee
Location: On-site
Role Requirements:
Bachelor's degree (preferably in Electrical Engineering or a related field) + 4 years of experience in medical device product safety compliance evaluations, and/or fully accredited test labs such as UL, CSA, Intertek, or Element.
Expert Knowledge:
In-depth knowledge of IEC 60601-1 3rd Edition (3.1 and 3.2) standards for medical electrical equipment, including particulars and collateral standards. Proven experience in applying these standards to electromagnetic medical devices.
Core Responsibilities:
- Conduct safety certification test assessments throughout the development lifecycle, including early stages, to provide necessary inputs to R&D for driving product development.
- Support development by planning, communicating periodic status updates, and identifying known risks (with proposed solutions) to R&D core teams.
- Perform safety testing of Client products in the Client 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 verification and validation (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 the governing standards and Client's QMS. This includes ensuring test samples meet production equivalency requirements.
- Use and maintain 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.
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