Lead Catheter Process Development Engineer

Pulse Biosciences, Inc.; San Francisco (CA); On-site; USD 130,000 - 155,000; Full time

Benefits offered by this job

Stock options

ESPP

401k retirement plan

Onsite gym

Mindfulness classes

Job summary

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

You will lead end-to-end process development—from extrusion and braiding to bonding, laser processing, electrical assembly, and qualification activities—to deliver robust, scalable medical devices for market launch.

Collaborate with R&D, quality and regulatory teams to ensure design controls and manufacturing readiness.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Science, Manufacturing Engineering, or related field.
• Minimum 5 years of medical device process development or manufacturing engineering experience.
• Experience with catheter manufacturing processes and device transfer to manufacturing.

Responsibilities

• Lead process development to transition catheter devices to scalable products.
• Perform DFM/ DFA analyses and tolerance studies to eliminate producibility risks.
• Develop and maintain component specifications and inspection criteria.
• Characterize catheter manufacturing processes including extrusion, braiding, bonding, and laser cutting.
• Develop inspection gauges and conduct MSA/Gauge R&R studies.
• Collaborate with Manufacturing to establish SPC methods and yield targets.
• Support process validation (IQ/OQ/PQ) and risk management requirements.

Skills

Catheter manufacturing

DOE/FMEA

CAD (SolidWorks)

GD&T (ASME Y14.5)

Statistical methods (CP/Cpk)

Education

Bachelor’s degree in Mechanical Engineering or related field

Master’s degree preferred

Tools

SolidWorks

Minitab

Job description

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

You will lead end-to-end process development—from extrusion and braiding to bonding, laser processing, electrical assembly, and qualification activities—to deliver robust, scalable medical devices for market launch.

Collaborate with R&D, quality and regulatory teams to ensure design controls and manufacturing readiness.