Medical Device Hardware Quality Technician

Aviso, LLC

Medical Device Hardware Quality Technician

Fremont, CA
Full Time
Paid
  • Responsibilities

    Benefits:

    401(k)

    Competitive salary

    Dental insurance

    Flexible schedule

    Role Overview Our client is seeking a hands-on Quality Technician in San Jose, CA. This is a lab-based role focused on the physical execution of Verification and Validation (V&V) testing for complex electromechanical and robotic systems. We are looking for a technical "doer" who can learn the environment quickly and start contributing to lab activities within 1 to 2 weeks.

    Key Responsibilities

    Physical Test Execution: Manually execute V&V test protocols, including functional, reliability, and performance testing on robotic platforms.

    Lab Setup: Physically set up test fixtures, specialized equipment, and test samples according to approved procedures.

    Documentation: Accurately record and report test data in real-time, maintaining strict adherence to Good Documentation Practices (GDP).

    Hardware Support: Partner with R&D during prototype builds; assist in the physical assembly and teardown of design iterations and engineering studies.

    Issue Escalation: Identify, document, and immediately escalate nonconformance or unexpected test results to the engineering team.

    Failure Analysis: Support the hands-on investigation and root cause analysis of physical test failures.

    Lab Compliance: Ensure all lab activities comply with FDA and ISO 13485 standards, keeping all test records and logs audit-ready.

    Qualifications

    Experience: hands-on quality, manufacturing, or test role. Medical device experience is highly preferred.

    Education: Associate’s degree in a technical field or equivalent experience. Open to recent graduates or candidates with technical backgrounds who demonstrate strong technical aptitude.

    Technical Skills: Proven experience using measurement tools like calipers, micrometers, and multimeters.

    Documentation: Strong understanding of GDP; experience with test execution in a regulated environment (FDA or ISO).

    Communication: Ability to clearly explain testing results and collaborate with Manufacturing and R&D teams.

    Aptitude: A "tinker" mindset with the ability to work around complex electromechanical systems and software-driven devices.

    Work Environment and Schedule

    Fully Onsite: This role is 100% onsite in San Jose; it is not a remote or desk-only position.

    Physical Requirements: Work is performed in an R&D lab (not a cleanroom) and requires standing for extended periods and manually handling robotic equipment.

    Overtime: Candidates must be open to working overtime as needed to meet project deadlines.