Sr. Technician, Catheter Engineering

About the Role

The Sr. Technician will be responsible to build, test, and refine catheter-based medical devices that deliver life-changing therapy to patients. Working closely with our engineering team, this individual will fabricate prototypes, execute verification tests, and maintain precise documentation to advance our next-generation therapeutic platforms. The ideal candidate is a skilled, detail-oriented builder with experience in a regulated medtech or biotech environment.

To Make an Impact, You Will:

• Build and assemble mechanical, electro-mechanical, and catheter-based prototypes in accordance with engineering drawings, work instructions, build specifications, and verbal direction from engineers.
• Demonstrate proficiency in fine soldering techniques, including small gauge wire termination, surface mount component placement, and high/low voltage cable assembly fabrication in accordance with applicable workmanship standards.
• Execute design verification and validation tests, mechanical and electrical testing following established test protocols; record and report results accurately.
• Maintain laboratory notebooks, test data logs, and documentation in compliance with design controls and quality system requirements.
• Assist engineers with troubleshooting assembly issues, fixture development, and process modifications; document findings and corrective actions.
• Fabricate and maintain test fixtures, jigs, and tooling to support prototype builds and verification activities.
• Support design transfer by creating work instructions, documenting assembly processes, and training production staff.
• Maintain a clean, organized, and safe laboratory and cleanroom environment in accordance with applicable procedures.

To Excel, You Will Bring:

• Associate or Bachelor's degree in a technical field preferred; or equivalent hands-on experience.
• Minimum 5 years of hands-on lab or cleanroom experience, preferably within a regulated medical device or biotech environment.
• Experience building and assembling catheter-based devices, electro-mechanical assemblies, or similar precision medical device components.
• Familiarity with quality systems and standards such as ISO 13485 and FDA design controls (21 CFR Part 820).
• Experience executing and documenting test protocols in a design controls environment.
• Proficient in CAD tools (SolidWorks preferred) and GD&T per ASME Y14.5; familiarity with statistical software (Minitab or equivalent) preferred.
• Working knowledge of catheter materials including thermoplastic polymers (PEBAX, nylon, polyurethane, PTFE), metallic components (nitinol, stainless steel, platinum-iridium), and adhesive systems.
• Strong analytical and problem-solving skills; experience with root cause analysis tools including FMEA, fishbone diagrams, 8D, and 5 Whys.
• Cleanroom experience preferred (ISO Class 7 or 8); strong project management skills with ability to manage multiple concurrent programs.
• Strong written and verbal communication skills; able to work independently and collaboratively in a fast-paced, cross-functional environment.
• Ability to work conscientiously and with minimal direction, using good judgement and taking initiative to accomplish assigned tasks.
• Ability to work as a team member, multi-task, and adapt to the changing priorities of a dynamic, fast-growing company.
• Occasional travel may be required up to 15% of the time, primarily for supplier qualification, contract manufacturing, and design transfer activities.
• Ability to lift 10-15 pounds.

Pay Range:

Compensation is determined based on a wide range of factors including location, job-related skills, experience, education, and training. It is not typical for an individual to be hired at or near the top of the range for their role. This pay range is specific to Northern California location. Pay range: $30.00-$45.00 per hour. This position is located onsite in Hayward, CA and candidates must reside in the San Francisco Bay Area. No relocation offered.