Hardware Test Engineer (Medical Device)
Role details
Job location
Tech stack
Job description
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., * 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.
Requirements
Do you have experience in Troubleshooting schematics?, * Education: Bachelor's degree in Electrical Engineering, Biomedical Engineering, or a related technical field.
- Experience: 3 to 5+ years of hands-on experience in hardware testing, verification, or validation.
- Technical Skills: Strong understanding of electronics, circuit schematics, and board-level troubleshooting.
- Lab Equipment: Proficiency with standard diagnostic tools (oscilloscopes, DMMs, logic analyzers, and function generators).
- Automation: Experience writing Python (or similar scripting languages) for test automation and test equipment communication (VISA, SCPI).
- Documentation: Proven ability to write clear, rigorous test cases, defect reports, and technical verification documentation., * 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)., + The ability to lift up to 30lbs
Benefits & conditions
Pulled from the full job description
- 401(k), * Canon Recruiting is committed to a diverse and inclusive workplace. Canon Recruiting is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.
- The pay range for this position is listed above. Base pay information is based on market location. We will consider for employment qualified applicants with arrest and conviction records. Our range of benefits may include health care and 401(k) savings plans.