What are the responsibilities and job description for the Product Certification Safety Engineer position at Katalyst HealthCares & Life Sciences?
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 Customer products in the Customer 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 are 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 Customer QMS. Includes ensuring test samples meet production equivalency requirements.
- Minimum Education 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 Element, etc.
- Expert knowledge of IEC 60601-1 3 rd 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.
- 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.
