Sr. Technician, Catheter Engineering

Pulse BiosciencesHayward, CA
$30 - $45Onsite

About The Position

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.

Requirements

  • 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.

Nice To Haves

  • Cleanroom experience preferred (ISO Class 7 or 8)
  • Familiarity with statistical software (Minitab or equivalent) preferred.

Responsibilities

  • 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.

Benefits

  • health insurance plans
  • supplemental insurance options
  • 401k retirement savings plan
  • Stock options awards
  • Employee Stock Purchase Plan (ESPP)
  • paid time off
  • paid holidays
  • flexible work schedule
  • wellness program
  • onsite gym
  • mindfulness classes
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