Source description
About the role
Position Title: Electrical Test Engineer Location: Onsite - Pleasanton, CA
Experience: 8+ years Contract: 12+ months, extension possible
Job Summary
The Electrical Test Engineer plays a key role in verifying and validating complex electro-mechanical medical devices that integrate hardware, software, and embedded technologies. This role focuses on electrical testing, documentation, lab development, and compliance with medical device standards to ensure product safety, reliability, and performance. The engineer will work hands-on with PCBA designs, FPGA systems, IEC 60601 requirements, LabView-based testing, and a wide range of electrical and EMC verification activities.
Position Overview
The engineer will be responsible for planning, performing, and documenting verification and integration testing for advanced medical devices. The work involves evaluating individual components and full system functionality, ensuring adherence to safety, performance, and regulatory expectations. This position requires strong experience in electrical engineering for medical devices, familiarity with design controls, and the ability to support both design teams and test lab activities.
Key Responsibilities
Electrical and EMC Testing
Perform electronics design testing and EMC pre-test activities for complex electro-mechanical medical device systems.
Identify required tests, prepare test environments, and confirm readiness before formal testing sessions.
Execute electrical verification activities including power control tests, AC voltage and current measurements, PCB and FPGA assessments, and analog/digital component testing.
Conduct EMC, EMI, ESD, and radio-related tests to ensure compliance with safety, regulatory, and industry standards.
Test Lab Support
Contribute to building and maintaining the Electrical Test Lab.
Set up test equipment, maintain lab safety, and follow best practices and safety protocols.
Support execution and documentation of Electronics Design and EMC tests.
Documentation and Design Control
Develop and maintain verification protocols, test reports, requirements documentation, and related technical records.
Ensure all verification procedures reflect applicable international standards.
Translate design inputs into effective verification strategies and protocols.
Support system architecture development and detailed design documentation.
Risk Analysis and Compliance
Participate in risk management activities including hazard analysis, Design FMEA, and Use FMEA.
Safely operate and test systems involving high/low voltage, thermal extremes, acoustic energy, and pressure systems.
Cross-Functional Collaboration
Support review and approval of design changes, process updates, and deviations for both new and existing products.
Collaborate closely with engineering, design, integration, and reliability teams, as well as external technical partners.
Communicate test findings and design recommendations clearly across teams.
Required Qualifications
Bachelor’s or Master’s degree in Electrical Engineering or a related technical discipline.
8+ years of experience in a regulated industry testing complex electro-mechanical systems, preferably medical devices.
Strong understanding of medical device design controls and product lifecycle processes aligned with standards such as ISO 9000, ISO 13485, IEC 60601, IEC 62304, EN 300 328, EN 300 330, and ISO 14971.
Hands-on experience with electrical testing involving temperature control, low-voltage and mains AC power control, PCBA, FPGA, and analog circuits such as ADC, DAC, OP-AMPs, FETs, transistors, and passive components.
Knowledge of communication interfaces including USB, RS-xxx, SPI, I2C, Microwire, SATA, and PCIE.
Proficiency with engineering tools such as oscilloscopes, logic analyzers, network analyzers, RF analyzers, spectrum analyzers, DVMs, Smith charts, and related equipment.
Skilled with requirement management, traceability tools, electrical simulation and design tools, and Microsoft Office applications.
Strong background in developing verification protocols, executing tests, generating reports, and conducting electrical verification under extreme environmental conditions.
Basic laboratory skills including material safety, chemical hygiene, personal protective equipment usage, contamination control, and job hazard analysis.
Strong teamwork mentality and ability to collaborate across disciplines.
Excellent written and verbal communication skills.
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