About the Role

The Sr. Process Development Engineer will be responsible to bridge early-stage device development and commercial-grade manufacturing. This individual will take first-in-human catheter devices and refine them into robust, manufacturable products ready for commercial launch. The ideal candidate will bring deep catheter engineering expertise, a manufacturing mindset, and a proven track record of successful medical device design transfer.

To Make an Impact, You Will:

• Lead process development activities to transition early-stage catheter devices from first-in-human configurations to commercially viable, scalable products.
• Perform DFM/DFA analyses and tolerance stack-up studies (worst-case and statistical) to eliminate producibility risks, define critical dimensions, and establish component acceptance criteria.
• Develop and maintain detailed component specifications, drawing requirements, and incoming inspection criteria, including AQL sampling plans, in alignment with device performance requirements and supplier capabilities.
• Characterize and optimize catheter manufacturing processes including extrusion, braiding, tip forming, thermal bonding, adhesive joining, and laser cutting to achieve robust, repeatable outcomes.
• Develop and optimize electrical assembly processes for catheter-integrated components, including fine-gauge wire termination, surface mount component placement, and high- and low-voltage cable assembly fabrication in compliance with applicable industry workmanship standards.
• Partner with Manufacturing Engineering on process validation (IQ, OQ, PQ) and process FMEAs; contribute to protocols, risk documentation, and control definitions to ensure regulatory compliance.
• Collaborate with Manufacturing Engineering to establish SPC methods, capability studies (Cp, Cpk), yield targets, and build monitoring frameworks that support production stability and COGS objectives.
• Develop inspection gauges and conduct MSA/gauge R&R studies to validate measurement system capability.
• Evaluate and qualify raw materials, adhesives, and components; assess material compatibility, processability, and biocompatibility implications.
• Initiate and manage engineering change orders (ECOs) to implement process improvements while maintaining design history file integrity.
• Ensure components and processes under development are compatible with sterilization methods (EO, gamma, e-beam) and packaging requirements in collaboration with quality and regulatory teams.
• Apply lean manufacturing principles to reduce waste and improve cycle times in preparation for commercial scale-up.
• Partner with suppliers and contract manufacturers to evaluate process capabilities, establish manufacturing requirements, and drive continuous improvement.
• Create and maintain manufacturing work instructions, assembly procedures, and process travelers to support design transfer and production readiness.
• Collaborate cross-functionally with R&D, quality, regulatory, and manufacturing teams to align process activities with design controls and program timelines.
• Mentor junior engineers and technicians on process-related problem solving and root cause analysis.

To Excel, You Will Bring:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Science, Manufacturing Engineering, or a related field; Master's degree preferred.
• Minimum 5 years of medical device process development or manufacturing engineering experience, with at least 3 years focused on catheter-based devices, including demonstrated experience taking a device from early-stage development to commercial manufacturing.
• Hands-on experience with catheter manufacturing processes including extrusion, braiding, thermal bonding, tip forming, adhesive assembly, and laser processing.
• Proficiency in tolerance stack-up analysis (worst-case and statistical) and working knowledge of statistical methods (Cp/Cpk, SPC, gauge R&R); DOE experience a plus.
• Experience supporting process validation (IQ, OQ, PQ) in a regulated medical device environment.
• Familiarity with FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971 risk management requirements.
• Experience developing component specifications and working with suppliers to establish and verify manufacturing capabilities.
• 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.

Pay Range:

Compensation is determined based on a wide range of factors including location, job-related skills, experience, education, and training. It is not typical for an individual to be hired at or near the top of the range for their role. This pay range is specific to Northern California location. Base salary range: $130k-$155k. This position is located onsite in Hayward, CA and candidates must reside in the San Francisco Bay Area. No relocation offered.