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Medical Device Hardware Quality Technician

Aviso, LLC
locationFremont, CA, USA
PublishedPublished: 6/14/2022
Technology

Job Description

Job DescriptionBenefits:

  • 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.