Hardware Test Engineer (Medical Device)

Job Description

Job Description

POSITION: Hardware Test Engineer

FULL-TIME/PART-TIME: Full-time/Direct Hire

LOCATION: Irvine, CA

SCHEDULE: 40hrs – M-F

PAY RANGE: $120,000 – $150,000 DOE

(Exact compensation may vary based on skills, experience, and location. Base pay information is based on market location.)

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.

JOB 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.

REQUIRED QUALIFICATIONS

• 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.

PREFERRED QUALIFICATIONS

• 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).

WORKING CONDITIONS:

• May on occasion be exposed to loud sounds and distracting noise levels, such as from office equipment.
• The ability to lift up to 30lbs
• Use of computers and technology

Here at Canon Recruiting, People are our priority, and we are committed to Include Diversity in every segment of who we are. It is only through our Diversity, we are made a stronger organization, and increase our ability to provide top tier candidates that our clients have come to know Canon for. We have an inclusive environment all employees are celebrated for their unique differences. The different perspectives and experiences of our workforce give us the competitive advantage that is essential for success in an ever-changing market. By promoting inclusion with the same enthusiasm, we devote to quality and competency, and using the experience from a diverse assortment of backgrounds and experiences, Canon is able to improve the services and value we deliver to clients, employees, and customers. At Canon, Diversification and Inclusiveness are much more than a corporate ambition; they are a critical component in our daily corporate life.

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.
For individuals with disabilities who would like to request an accommodation, please email View email address on ziprecruiter.com