Position Title: Electrical Test Engineer
Location: Pleasanton, CA (Onsite)
Experience: 8+ years
Contract Length: 12 months (extension possible)
Relocation: Candidates willing to relocate are welcome
Position Overview
We are seeking an experienced Electrical Test / FPGA Engineer to perform and document verification and integration activities for complex electro-mechanical medical devices with software. This role ensures the safety, efficacy, and compliance of medical devices by testing individual components and full systems.
The ideal candidate has strong experience across the product development life cycle and a solid understanding of systems engineering in the medical device industry. This role works closely with multi-disciplinary teams, including system, software, electrical, and mechanical engineers, as well as other stakeholders.
Key Responsibilities
- Perform electronics design and EMC pre-tests for complex electro-mechanical medical devices.
- Identify electrical tests, prepare test environments, and ensure all preconditions are met.
- Verify analog and digital electrical designs, including PCB, FPGA, low-voltage power control, AC voltage/current, and analog components (ADC, DAC, OP-AMP, FET, transistor, resistor, capacitor, inductor).
- Conduct EMC, EMI, ESD, and radio compliance testing.
- Support building and maintaining the Electrical Test Lab and follow lab safety protocols.
- Develop and maintain verification protocols, reports, requirements documents, and other technical documentation.
- Translate design inputs into test designs and protocols, supporting system architecture and detailed design documentation.
- Contribute to risk analysis, including hazards analysis, Design FMEA, and Use FMEA.
- Safely work with hazardous systems (high/low voltage, temperature, acoustic, pressure).
- Review and approve design/process changes and deviations for new or existing medical devices.
- Collaborate with internal and external stakeholders to ensure high-quality product design, development, and testing.
Required Qualifications
- Bachelor's or Master's degree in Electrical Engineering or related technical field.
- 8+ years of experience testing complex electro-mechanical systems in regulated industries.
- Strong knowledge of medical device design controls and product lifecycle standards (ISO 9000, ISO 13485, IEC 60601, IEC 62304, EN 300 328, EN 300 330, ISO 14971).
- Technical expertise in PCBA design, FPGA, analog/digital electronics, USB, RS-xxx, SPI, I2C, Microwire, SATA, PCIe, TECs, low-voltage and AC power control.
- Hands-on experience with design verification protocols, execution, and reporting, including EMC, EMI, ESD, and radio testing.
- Proficiency in engineering tools: spectrum analyzers, logic analyzers, network analyzers, oscilloscopes, RF analyzers, DVMs, Smith charts.
- Strong computer skills, including requirement management, traceability, electrical simulation, and general office tools.
- Knowledge of laboratory safety, chemical hygiene, personal protective equipment, contamination control, and hazard analysis.
- Excellent communication and teamwork skills; ability to build trust and maintain professional relationships.
