Senior Engineer, Process Development Engineer
About The Position
We are seeking a Process Development Engineer to take end-to-end ownership of delivery catheter development and manufacturing—from early prototype fabrication through validated clinical builds and into scalable commercial production. This individual will be the technical authority for catheter process development within the Advanced Manufacturing Engineering (AME) team, 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 development and manufacturing. The successful candidate will drive the transition from bench-built prototypes to robust, process-controlled clinical-grade assemblies, while progressively building Synchron’s internal catheter manufacturing capabilities—including equipment, tooling, process documentation, and workforce skills—to reduce reliance on external suppliers and accelerate development cycles.
Requirements
- Bachelor’s degree in mechanical engineering, biomedical engineering, materials science, or a related discipline
- 5+ years of experience in catheter or endovascular device process development and 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 multi-lumen, braided, and hybrid 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 DOEs to optimize catheter performance characteristics (trackability, pushability, kink resistance, torque response) through process levers
- Establish process capability (Cpk) data and statistical process controls for key catheter build 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 design verification builds to clinical-grade assemblies 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 Stentrode Kit R&D team to co-optimize catheter design for manufacturability and to translate design intent into scalable processes
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
11-50 employees
