Principal Engineer, NPD
Core
Lead the development of next-generation balloon expandable delivery systems for transcatheter heart valves, focusing on manufacturing process design, validation, and scaling from pilot to production.
Role type
Principal Engineer, New Product Development (NPD)
Builds
Class II/III medical device manufacturing processes and delivery systems
Domain
Medical device manufacturing / Cardiovascular implants
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Manufacturing process design, Design of Experiments (DOE), Statistical analysis, Validation strategy execution, Scaling and replication methodologies, Automation infrastructure (PLC/SCADA/MES), Cross-functional team leadership, Risk management, Change management, Critical-to-Quality (CTQ) analysis, Design for Manufacturability (DFM), Six Sigma, LEAN, Supplier development, cGMP compliance, EH&S principles
Preferred skills
Catheter assembly process technologies (adhesive/thermal bonding, tube flaring, coatings, vision systems), Mechanical systems (sensors, actuators, pneumatics, motors, drives), Machine safety principles, Bridging innovation with manufacturing reality
Technologies
PLCs, SCADA, MES, Industrial networking, Electronic records
Responsibilities
Develop manufacturing processes suitable for Class II/III medical devices; Design and execute experiments to establish process windows; Lead validation strategies for equipment, software, and processes; Develop scaling approaches across sites; Design and support manufacturing automation and digital infrastructure; Lead matrixed teams across organizations and suppliers; Serve as a trusted advisor to R&D, Manufacturing, Quality, and Project Management
Seniority
Principal, hands-on IC with strategic scope
