Medical Device Hardware Quality Technician

Aviso, LLC; Fremont (CA); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

401(k)

Competitive salary

Dental insurance

Flexible schedule

Job summary

Aviso, LLC in San Jose, CA seeks a hands-on Quality Technician for a lab-based V&V role focused on electromechanical and robotic systems. You will set up test fixtures, run functional, reliability, and performance tests, and document data in real time. The role requires GDP adherence and collaboration with R&D during prototype builds. Onsite work with potential overtime.

Qualifications

• Hands-on quality, manufacturing, or test role experience.
• Associate’s degree or equivalent in a technical field.
• Understanding of GDP and testing in regulated environments (FDA/ISO).
• Proven ability to clearly explain testing results to cross-functional teams.
• Tinker mindset with ability to work around complex electromechanical systems.

Responsibilities

• Manually execute V&V test protocols including functional, reliability, and performance testing on robotic platforms.
• Physically set up test fixtures, equipment, and samples per procedures.
• Record and report test data in real time, maintaining GDP.
• Collaborate with R&D during prototype builds; assist in assembly and teardown of iterations.
• Identify and escalate nonconformance or unexpected results to engineering.
• Support investigations and root cause analysis of physical test failures.
• Ensure lab activities comply with FDA/ISO 13485 standards; maintain audit-ready logs.

Skills

Hands-on quality

Regulatory understanding

Test execution communication

Education

Associate degree or equivalent

Tools

Calipers

Micrometers

Multimeters

Job description

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

• Manually execute V&V test protocols, including functional, reliability, and performance testing on robotic platforms.
• Physically set up test fixtures, specialized equipment, and test samples according to approved procedures.
• Accurately record and report test data in real‑time, maintaining strict adherence to Good Documentation Practices (GDP).
• Partner with R&D during prototype builds; assist in the physical assembly and teardown of design iterations and engineering studies.
• Identify, document, and immediately escalate nonconformance or unexpected test results to the engineering team.
• Support the hands‑on investigation and root cause analysis of physical test failures.
• Ensure all lab activities comply with FDA and ISO 13485 standards, keeping all test records and logs audit‑ready.

Qualifications

• Hands‑on quality, manufacturing, or test role experience; medical device experience is highly preferred.
• Associate’s degree in a technical field or equivalent experience. Open to recent graduates or candidates with technical backgrounds who demonstrate strong technical aptitude.
• Proven experience using measurement tools like calipers, micrometers, and multimeters.
• Strong understanding of GDP; experience with test execution in a regulated environment (FDA or ISO).
• Ability to clearly explain testing results and collaborate with Manufacturing and R&D teams.
• 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.