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Medical Device Test Engineer Jobs in California (NOW HIRING)

The Test Engineer is a hands-on individual contributor on the Test Engineering team, responsible ... Working familiarity with medical device QMS practices and applicable standards (e.g., ISO 13485 ...

The Test Engineer is a hands-on individual contributor on the Test Engineering team, responsible ... Working familiarity with medical device QMS practices and applicable standards (e.g., ISO 13485 ...

Senior Test Engineer Location : Pleasanton CA Experience: 6+ Years Key Responsibilities * Design ... Comply with regulatory requirements and documentation standards for Medical Device IT systems (e.g ...

The Senior Test Engineer is a hands-on individual contributor on the Test Engineering team ... Working knowledge of medical device QMS practices and applicable standards (e.g., ISO 13485, IEC ...

Test Engineer II

Menlo Park, CA · On-site

$75 - $80/hr

... medical-device / ISO-style design controls). There will be close collaboration with a senior engineer who owns the test requirements, calibration methodology, and quality standards Execution will be ...

Test Engineer Location : Irvine, CA Duration : Full-time / Contract : * Experience in Embedded ... Medical Device Experience is an advantage * BS in Electrical & Electronics Engineering ...

It blends manufacturing test engineering, Python-based test automation, electromechanical ... Experience in medical device manufacturing or other regulated industries such as aerospace and ...

It blends manufacturing test engineering, Python-based test automation, electromechanical ... Experience in medical device manufacturing or other regulated industries such as aerospace and ...

The Senior Test Engineer will work with a team of dedicated individuals within a product ... Medical Device Verification/Validation experience is required * Understanding of design controls ...

The Senior Test Engineer will work with a team of dedicated individuals within a product ... Medical Device Verification/Validation experience is required * Understanding of design controls ...

... device test) * Develop and run board-level test - functional, structural (boundary scan/JTAG), in ... Additional compensation: equity grant per company guidelines; medical / dental / vision; 401(k) ...

The Senior Test Engineer is a hands-on individual contributor on the Test Engineering team ... Working knowledge of medical device QMS practices and applicable standards (e.g., ISO 13485, IEC ...

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Support engineering tests by executing defined test methods * Record and maintain documentation as ... Comfortable working in a regulated environment (medical device experience is a plus) * Ability to ...

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Medical Device Test Engineer information

What are the key skills and qualifications needed to thrive as a Medical Device Test Engineer, and why are they important?

To thrive as a Medical Device Test Engineer, you need a solid background in biomedical engineering or a related field, strong analytical skills, and a deep understanding of medical device regulations such as FDA and ISO standards. Familiarity with test automation tools, data acquisition systems, and software like LabVIEW or MATLAB is typically required, along with certifications such as ISTQB or Six Sigma being advantageous. Strong attention to detail, problem-solving abilities, and effective communication are essential soft skills for collaborating with cross-functional teams and documenting results. These skills and qualifications ensure that medical devices are safe, effective, and compliant with regulatory standards, ultimately protecting patient health.

What is the difference between Medical Device Test Engineer vs Quality Assurance Engineer?

AspectMedical Device Test EngineerQuality Assurance Engineer
CredentialsEngineering degree, certifications like ISTQB or ISO 13485 familiarityEngineering or related degree, ISO 9001/13485 certifications often preferred
Work EnvironmentLaboratories, manufacturing facilities, R&D settingsQuality departments, manufacturing plants, compliance offices
Industry UsageFocuses on testing medical devices for safety and functionalityEnsures overall quality management and compliance processes

Medical Device Test Engineers primarily focus on testing and validating medical devices to ensure safety and performance, often working closely with R&D and manufacturing teams. Quality Assurance Engineers oversee broader quality systems, compliance, and process improvements. While both roles aim to ensure product safety, the Test Engineer concentrates on device testing, whereas the QA Engineer manages quality systems and standards compliance.

What are some common challenges faced by Medical Device Test Engineers during product validation, and how are they typically addressed?

Medical Device Test Engineers often encounter challenges such as ensuring compliance with stringent regulatory standards (like FDA or ISO), managing tight project timelines, and troubleshooting complex device failures during validation. Addressing these challenges usually involves thorough documentation, close collaboration with cross-functional teams (such as design, quality, and regulatory), and implementing robust test protocols. Regular communication and proactive risk assessment also help anticipate potential issues and maintain project momentum.

What does a Medical Device Test Engineer do?

A Medical Device Test Engineer is responsible for designing, developing, and executing tests to ensure that medical devices meet regulatory standards and function safely and effectively. They create test plans, perform verification and validation activities, and analyze test data to identify potential issues. Their work is crucial to ensure that devices are reliable and compliant with industry regulations before reaching the market.
What are popular job titles related to Medical Device Test Engineer jobs in California? For Medical Device Test Engineer jobs in California, the most frequently searched job titles are:
What cities in California are hiring for Medical Device Test Engineer jobs? Cities in California with the most Medical Device Test Engineer job openings:
Infographic showing various Medical Device Test Engineer job openings in California as of July 2026, with employment types broken down into 78% Full Time, 14% Part Time, and 8% Contract. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution.
Hardware Test Engineer (Medical Device)

Hardware Test Engineer (Medical Device)

Canon Recruiting Group

Irvine, CA

Other

Medical, Retirement

Posted 6 hours ago


Job description

POSITION: Hardware Test Engineer

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

LOCATION: Irvine, CA

SCHEDULE: 40hrs – M-F

PAY RANGE: $100,000 – $120,000 DOE

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

POSITION SUMMARY

The Hardware Test Engineer will be a member of the hardware team developing a unique sensing wearable. The candidate will be responsible for the development and execution of hardware test protocols and the writing of test reports. The ideal candidate will have experience in hardware test execution, interfacing various hardware components together, and writing reports to document their results. A successful candidate will be self-motivated, naturally inquisitive, and a born problem solver. This includes having a broad knowledge of testing principles and use of lab instrumentation such as data acquisition systems, multimeters, and source-measure units (SMUs). The role will be responsible for working with the hardware and software teams to understand the test system requirements, build and assemble test fixtures, assist in the development of software to operate test fixtures, and validate that the test system is operating as intended.

KEY RESPONSIBILITIES

  • Develop and execute test protocols according to hardware test requirements.
    • Work with the hardware and software teams to develop test solutions for both hardware development and manufacturing.
    • Contribute to the development, assembly, and bring-up of test fixtures, which may be used for electrical, optical, or mechanical testing for design verification, reliability, or in-process testing.
    • Work with hardware team and technicians to develop processes and reports for test fixture execution.
    • Track test failures and perform statistical data analysis to identify hardware issues and drive their resolution.
    • Be an active part of the hardware design review process to ensure design for testability.


    KNOWLEDGE, SKILLS & ABILITIES

    • Broad hardware test knowledge including controlling test instrumentation, data acquisition, and methods of test automation.
    • Writing test plans, test reports, and test protocols that can be executed by other engineers or technicians.
    • Assemble and bring-up hardware test fixtures.
    • Documentation and presentation of test results to other members of the team and contributing to root cause analysis.

    EDUCATION & EXPERIENCE

    • BA/BS degree in Electrical Engineering, Computer Engineering, Mechanical Engineering, or related fields.
    • Minimum 2 years of experience in a Hardware Test Engineer role or similar.
    • Proficient in writing test documentation: test plan, test case, and test report.
    • Experience with Python or a similar programming language.
    • Experience in optical testing of detectors and lasers.
    • Experience with CAD (SolidWorks or similar software) and reading mechanical drawings.
    • Experience with the testing process of medical devices.
    • Desirable experience in electrical assembly methods (soldering).
    • Desirable experience with the test cycle for an FDA regulated medical device.

     

    Duties are performed in an office environment using standard office equipment. While performing the duties of this job, the employee must occasionally lift or move office products and supplies, up to 20 pounds. This role routinely uses standard office equipment such as computers, phones, and photocopiers. May require occasional overnight travel (<10%).

      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 hr@canonrecruiting.com