Principal, Process Development Engineer-CA

Synchron Inc. • San Diego, CA

6d • $140,000 - $200,000 • Onsite

About The Position

Synchron is seeking a Process Development Engineer to take end-to-end ownership of catheter design and development within their system. This individual will be the technical authority for next-generation catheter design and process development within the Advanced Manufacturing Engineering (AME) team. They will be responsible for establishing, characterizing, and scaling the processes required to build Synchron’s endovascular delivery system reliably and repeatably. This role sits at the intersection of product design, development, and manufacturing, driving the transition from bench-built prototypes to robust, process-controlled assemblies.

Requirements

• Bachelor’s degree in mechanical engineering, biomedical engineering, materials science, or a related discipline.
• 8+ years of experience in catheter or endovascular device design, process development, or manufacturing.
• Expertise in catheter construction processes: braiding, coiling, liner extrusion, jacket reflowing, tip forming, bonding, and lamination.
• Strong command of process validation methodology (IQ/OQ/PQ), DOE, SPC, and process capability analysis.
• Experience building internal manufacturing capabilities from the ground up, including equipment specification, facility layout, and team development.

Nice To Haves

• Neurovascular or cardiovascular catheter manufacturing experience.
• Experience with catheter constructions for tortuous anatomy access.
• Demonstrated experience taking catheter products from prototype through process validation and into clinical or commercial production.
• Background in polymer processing and material science relevant to catheter materials (PTFE, Pebax, nylon, HDPE, polyimide).
• Experience supporting IDE or PMA submissions with manufacturing process documentation.

Responsibilities

• Own the development, characterization, and eventual validation of all manufacturing processes for the delivery catheter system, braid/coil winding, jacket reflowing, tip forming, bonding, and hub assembly.
• Define process parameters, operating windows, and critical-to-quality attributes for each catheter construction step.
• Develop and execute engineering studies to optimize catheter performance characteristics (trackability, pushability, kink resistance, torque response) through design and process levers.
• Establish process capability (Cpk) data and statistical process controls for key catheter assembly steps.
• Author and maintain process specifications, work instructions, and manufacturing batch records.
• Partner with Quality to ensure catheter manufacturing documentation supports regulatory submissions and audit readiness.
• Lead the catheter build progression from R&D prototypes through builds under full design controls.
• Define build strategies, lot sizing, and acceptance criteria for each stage of catheter maturity.
• Own the process-side inputs for design transfer, ensuring manufacturing readiness ahead of clinical milestones.
• Support clinical supply planning by establishing build capacity, cycle times, and yield projections for catheter production.
• Partner closely with the wider R&D team to optimize catheter design for system performance.
• Work with supply chain and procurement on supplier development, material sourcing, and contract manufacturer management.
• Coordinate with clinical operations on build scheduling, device labeling, and clinical supply logistics.

Benefits

• Subsidized medical and dental insurance coverage for you and your dependent(s)
• Life insurance, short-term disability, long-term disability
• 401k
• Discretionary unlimited PTO
• Flexible Spending Account for you and your dependent(s), with eligible plan elections
• Commuter benefits for NY employees

What This Job Offers

• Job Type: Full-time
• Career Level: Principal