Principal, Process Development Engineer-CA (opens in new tab) San Diego, CA →

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process. Principal, Process Development Engineer-CA 6 days ago Requisition ID: 1034 Salary Range: $160,000.00 To $180,000.00 Annually Principal, Process Development Engineer About Synchron Synchron’s vision is to build non-surgical brain–computer interfaces at global scale that protect the fundamental human rights of freedom of expression and autonomy. Our first mission is to develop motor decoders that restore the ability of 15 million people with paralysis to interact with the digital world. Our second mission is to develop whole-brain cognitive decoders that enable hundreds of millions of people with cognitive decline to preserve and expand their agency as cognition changes over time. In pursuing these goals, we aim not only to help humans flourish, but also to drive fundamental discoveries in human intelligence. Our team operates at the intersection of healthcare and technology, translating breakthrough research into real-world, safety-critical systems. Principal Process Development Engineer Advanced Manufacturing Engineering Team Employment Type : Full-Time About the Role We are seeking a Process Development Engineer who can straddle the line between R&D and process development to take end-to-end ownership of catheter design and development across our system. This individual will be the technical authority for next generation catheter design and 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 design, development, and manufacturing. The successful candidate will drive the transition from bench-built prototypes to robust, process-controlled assemblies. Key Responsibilities Delivery System Process Development & Ownership 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. Prototype Through Clinical Build Progression 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. Cross-Functional Collaboration 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. Required Qualifications 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. Preferred Qualifications 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. Compensation The base salary range for this role is $160,000 – $180'000 depending on experience, skills, and qualifications. In addition to base salary, this role may be eligible for discretionary bonuses and/or equity grants , subject to board approval and company policy. We are unable to offer visa sponsorship for this position currently. Benefits (for W-2, full-time, exempt employees in the US only) ***Intern positions not eligible Subsidized medical and dental insurance coverage for you and your dependent(s) 401k Discretionary unlimited PTO Flexible Spending Account for you and your dependent(s), with eligible plan elections Commuter benefits for NY employees Equal Employment Opportunity (EEO) Synchron is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and provide equal employment opportunities without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other characteristic protected by applicable law. If you need a reasonable accommodation during the application or interview process, please let us know. Join Us At Synchron, you will be part of a transformative mission and you will work alongside driven people who believe in the power of collaboration and innovation to make a lasting impact. If you are excited to stretch your skills and contribute to something meaningful, apply now and build the future with us. #J-18808-Ljbffr Synchron