Experience Required : 5 10 years (Medical Devices experience is mandatory)
Role Requirements :
1. Minimum Education and Experience :
Bachelor's Degree in Electrical Engineering (or related field) 4 years of experience in medical device product safety compliance evaluations and / or fully accredited test labs (e.g., UL, CSA, Intertek, Element).
2. Expertise :
In-depth knowledge of IEC 60601-1 3rd Edition (3.1 and 3.2) standards for medical electrical equipment, including collateral and particular standards.
Proven experience applying these standards to Electromedical (EM) devices.
Demonstrated ability to effectively collaborate with cross-functional teams.
Core Responsibilities :
Perform safety certification test assessments throughout the development lifecycle, including early stages, to guide R&D and drive product development.
Support development activities by planning, providing status updates, and addressing risks with proposed solutions for R&D core teams.
Conduct safety testing for products in both internal safety labs and external labs.
Prepare documentation required for safety certification activities, including :
Isolation diagrams
Dielectric and leakage current testing
Construction evaluation using IEC-generated test report forms
Coordinate with internal and external labs, technicians, and design engineers to achieve timely, cost-effective results, from quote requests to final deliverables.
Collaborate with teams to ensure the successful execution of required testing and de-risk product launches through pre-verification test rehearsals.
Document and execute all verification and validation (V&V) tests per medical device QSR and ISO 13485 standards.
Prepare precise, detailed safety verification test plans and reports with a focus on clarity and accuracy.
Plan and execute safety testing of electrical equipment for global market access, ensuring compliance with product safety testing requirements and QMS procedures.
Ensure that test samples meet production equivalency requirements for certification.
Maintain and calibrate commonly used safety equipment, and provide guidance for external labs conducting certification testing.
Apply working knowledge of ISO 14971 Risk Management for Medical Devices in safety compliance activities.
Plan and oversee EMC testing per IEC 60601-1-2, including test planning and associated procedures.
Skills and Competencies :
Strong technical writing and communication skills (will be assessed during the interview).
Ability to communicate complex concepts in both formal / informal presentations and technical reports.
Experience with safety certification testing equipment and maintenance procedures.
Familiarity with EMC test planning, procedures, and associated practices.
Keep a pulse on the job market with advanced job matching technology.
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