Senior Catheter Engineer - Precision Med Devices

Pulse Biosciences, Inc.; Hayward (CA); On-site; USD 85,962,000 - 128,943,000; Full time

Job summary

Pulse Biosciences, Inc. in Hayward, CA, is seeking a Sr. Technician to build, test, and refine catheter-based medical devices delivering life-changing therapy.

You will fabricate prototypes, execute verification tests, and maintain precise documentation in a regulated medtech environment. The ideal candidate has 5+ years of hands-on lab or cleanroom experience, familiarity with ISO 13485 and FDA design controls, and strong CAD (SolidWorks) and GD&T skills to support design transfer and

Qualifications

• 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 ISO 13485 and FDA design controls (21 CFR Part 820).
• Experience executing and documenting test protocols in a design controls environment.

Responsibilities

• Build and assemble mechanical, electro-mechanical, and catheter-based prototypes in accordance with engineering drawings, instructions, build specifications, and engineer direction.
• Demonstrate proficiency in fine soldering techniques and high/low voltage cable assembly fabrication per workmanship standards.
• Execute design verification and validation tests, mechanical and electrical testing following established 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 procedures.

Skills

Hands-on lab/cleanroom experience

Analytical problem solving

Project management

Communication skills

Education

Associate's or Bachelor's degree in technical field

Tools

SolidWorks

GD&T ASME Y14.5

Minitab

FMEA

Job description

Pulse Biosciences, Inc. in Hayward, CA, is seeking a Sr. Technician to build, test, and refine catheter-based medical devices delivering life-changing therapy.

You will fabricate prototypes, execute verification tests, and maintain precise documentation in a regulated medtech environment. The ideal candidate has 5+ years of hands-on lab or cleanroom experience, familiarity with ISO 13485 and FDA design controls, and strong CAD (SolidWorks) and GD&T skills to support design transfer and