Senior Catheter Process Engineer - From Lab to Commercial Scale

Pulse Biosciences; Hayward (CA); On-site; USD 130,000 - 155,000; Full time

Benefits offered by this job

Health insurance

401k

Stock options

ESPP

Paid time off

Job summary

Pulse Biosciences is seeking a Sr. Process Development Engineer in Hayward, CA to bridge early-stage catheter device development with commercial manufacturing.

You will refine devices into robust, manufacturable products ready for launch, bringing deep catheter engineering expertise and a manufacturing mindset. The ideal candidate has 5+ years in medical device process development, hands-on catheter fabrication experience, and a track record of successful design transfer to production.

Qualifications

• Bachelor’s degree in Mechanical, Biomedical, Materials, Manufacturing Engineering or related field; Master’s preferred.
• Minimum 5 years of medical device process development or manufacturing engineering experience, with catheter-based devices.
• Strong CAD skills and experience with GD&T; knowledge of ISO 13485 and FDA QSR is a plus.

Responsibilities

• Lead process development to transition early-stage catheter devices to commercially viable products.
• Perform tolerance stack-up analyses and define critical dimensions for producibility.
• Develop and maintain component specifications, drawings, and acceptance criteria with suppliers.
• Characterize and optimize catheter manufacturing processes including extrusion, braiding, tip forming, and laser cutting.
• Develop electrical assembly processes for catheter-integrated components ensuring regulatory compliance.
• Collaborate with Manufacturing Engineering on IQ/OQ/PQ, FMEAs, and process validation.

Skills

Analytical skills

Problem solving

Communication

Independence

Teamwork

Education

Bachelor’s degree in Mechanical/Biomedical/Materials/Manufacturing Engineering (Master’s preferred)

Tools

SolidWorks

GD&T

Minitab

Job description

Pulse Biosciences is seeking a Sr. Process Development Engineer in Hayward, CA to bridge early-stage catheter device development with commercial manufacturing.

You will refine devices into robust, manufacturable products ready for launch, bringing deep catheter engineering expertise and a manufacturing mindset. The ideal candidate has 5+ years in medical device process development, hands-on catheter fabrication experience, and a track record of successful design transfer to production.