Electrical Test Engineer- Medical Device
- Pleasanton, California, United States
- Pleasanton, California, United States
Über
Job Summary:
The Electrical Test Engineer will support verification and integration activities for complex electro-mechanical medical devices. This role focuses on evaluating electrical design elements, ensuring compliance with safety and regulatory standards, and contributing to high-quality product development. The position works closely with cross-functional engineering teams to support testing, documentation, risk analysis, and product lifecycle activities for class II medical devices.
Key Responsibilities:
- Perform electrical design and electromagnetic compatibility pre-test activities for electro-mechanical medical device products
- Identify required electrical tests, prepare test environments, and confirm all preconditions are met
- Conduct electrical verification of analog and digital systems, including power control, PCB assemblies, FPGA, and component-level testing
- Conduct compliance testing such as electromagnetic compatibility, electromagnetic interference, electrostatic discharge, and radio testing
- Support development and maintenance of verification protocols, reports, requirements, and related documentation
- Assist in building and maintaining the electrical test laboratory and follow all safety practices
- Verify translation of design inputs into test protocols and support system architecture documentation
- Participate in risk analysis activities including hazard analysis, design failure mode and effects analysis, and use failure mode and effects analysis
- Support review of design and process changes for new and existing medical device products
- Collaborate with engineering teams and external partners to support product design, testing, and reliability initiatives
Required Qualifications:
- Bachelor's or master's degree in engineering or a related technical field
- Eight or more years of experience testing complex electro-mechanical systems in a regulated industry
- Knowledge of medical device design controls and standards including ISO 9000, ISO 13485, IEC 60601, IEC 62304, EN , EN , and ISO 14971
- Strong background in electrical testing including temperature control, low voltage power systems, PCB assemblies, FPGA, analog components, and digital communication interfaces
- Proficiency with engineering tools such as spectrum analyzers, logic analyzers, oscilloscopes, network analyzers, and RF communication analyzers
- Experience developing and executing verification protocols and reports, including testing for temperature, acoustic, pressure, EMC, EMI, ESD, and radio standards
- Proficient in requirement management, traceability, electrical design tools, electrical simulation tools, and standard office software
- Ability to work safely with high and low voltage systems, temperature-controlled environments, and acoustic or pressure-based systems
- Strong communication skills and ability to work effectively in multidisciplinary teams
Preferred Qualifications:
- Experience with acoustic systems
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.
Pay Range: $60/hr to $70/hr
Sprachkenntnisse
- English
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