Senior Process Development Engineer

Sr. Process Development Engineer, Catheter Engineering

San Francisco Bay Area (East Bay), onsite | Full-time

Position Summary

An innovative medical device company is hiring a Sr. Process Development Engineer to help bring its next-generation catheter technology to market. This role bridges early-stage development and commercial manufacturing: you’ll take early clinical catheter devices and refine them into robust, manufacturable products ready for launch. It’s ideal for someone with deep catheter engineering expertise, a manufacturing mindset, and a track record of successful design transfer.

Responsibilities

Lead process development to move catheter devices from first-in-human configurations to scalable commercial products Perform DFM/DFA analyses and tolerance stack-ups (worst-case and statistical), and define critical dimensions and component acceptance criteria Develop component specifications, drawing requirements, and incoming inspection criteria, including AQL sampling plans Characterize and optimize catheter processes: extrusion, braiding, tip forming, thermal bonding, adhesive joining, and laser cutting Develop electrical assembly processes for catheter-integrated components, including fine-gauge wire termination, surface-mount placement, and high- and low-voltage cable assembly Partner with Manufacturing Engineering on process validation (IQ/OQ/PQ), pFMEAs, SPC, capability studies (Cp/Cpk), and yield targets Develop inspection gauges and conduct MSA and gauge R&R studies Evaluate and qualify materials, adhesives, and components for processability and biocompatibility Manage ECOs while maintaining design history file integrity Ensure compatibility with sterilization methods (EO, gamma, e-beam) and packaging requirements Apply Lean principles to reduce waste and cycle time for commercial scale-up Partner with suppliers and contract manufacturers on process capability and continuous improvement Create work instructions, assembly procedures, and process travelers for design transfer Mentor junior engineers and technicians on problem solving and root cause analysis

Requirements

BS in Mechanical, Biomedical, Materials Science, or Manufacturing Engineering, or a related field; MS preferred 5+ years of medical device process development or manufacturing engineering experience, including 3+ years on catheter-based devices Proven experience taking a device from early-stage development to commercial manufacturing Hands-on catheter manufacturing experience: extrusion, braiding, thermal bonding, tip forming, adhesive assembly, and laser processing Proficiency in tolerance stack-up analysis and statistical methods (Cp/Cpk, SPC, gauge R&R); DOE a plus Experience supporting IQ/OQ/PQ in a regulated environment Familiarity with 21 CFR 820, ISO 13485, and ISO 14971 SolidWorks and GD&T (ASME Y14.5); Minitab preferred Working knowledge of catheter materials: PEBAX, nylon, polyurethane, PTFE, nitinol, stainless steel, platinum-iridium, and adhesive systems Root cause analysis tools: FMEA, fishbone, 8D, 5 Whys Cleanroom experience (ISO Class 7/8) preferred Strong project management and communication skills Up to 15% travel for supplier and contract manufacturer activities

Compensation and Location

Base salary of $130K–$155K, plus stock options and ESPP Onsite in the East Bay. Candidates must live in the SF Bay Area; relocation isn’t offered.