Hardware Test Engineer (Medical Device)

Canon Recruiting Group•Irvine, CA

1d•Onsite

About The Position

The Hardware Test Engineer will be responsible for verifying, validating, and troubleshooting medical device hardware components and systems. Working closely with cross-functional R&D and manufacturing teams, this role focuses on creating and executing test plans that ensure device reliability, performance, and strict regulatory compliance. The ideal candidate brings hands-on experience in a laboratory environment, utilizing standard test instrumentation to diagnose board-level and system-level issues, alongside using scripting languages to automate verification testing.

Requirements

Bachelor’s degree in Electrical Engineering, Biomedical Engineering, or a related technical field.
3 to 5+ years of hands-on experience in hardware testing, verification, or validation.
Strong understanding of electronics, circuit schematics, and board-level troubleshooting.
Proficiency with standard diagnostic tools (oscilloscopes, DMMs, logic analyzers, and function generators).
Experience writing Python (or similar scripting languages) for test automation and test equipment communication (VISA, SCPI).
Proven ability to write clear, rigorous test cases, defect reports, and technical verification documentation.

Nice To Haves

Experience working within ISO 13485 or FDA-regulated (21 CFR Part 820) environments.
Familiarity with medical device safety and compliance standards (e.g., IEC 60601-1).
Experience with environmental and reliability testing (thermal, shock, vibration, EMI/EMC).
Knowledge of hardware communication protocols (I2C, SPI, UART, CAN, Bluetooth).

Responsibilities

Design, set up, and execute comprehensive hardware verification and validation (V&V) protocols for medical device electronics and PCBAs.
Diagnose, troubleshoot, and perform root-cause analysis on hardware failures down to the component level.
Utilize standard lab equipment (oscilloscopes, multimeters, power supplies, and data acquisition systems) to validate hardware performance against design specifications.
Develop and maintain automated test scripts (e.g., Python) to control lab equipment, streamline data collection, and ensure repeatable test execution.
Collaborate with design engineers to review schematics, understand system architecture, and define test coverage.
Document strict, compliant test plans, generate detailed verification reports, and maintain traceability matrices in alignment with quality management standards.