Electrical Engineer (Medical Devices)

Job DescriptionJob DescriptionJob Description: Electrical Engineer (Medical Devices)

Location: Lake Forest, CA
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.