Senior Engineer, New Product Introduction
Core
Leads the commercialization of Class III implantable Transcatheter Heart Valve (THV) products, driving supply chain and manufacturing readiness from early development through product launch.
Role type
Senior NPI Engineer (Medical Devices)
Builds
Scalable manufacturing processes and global product delivery for cardiovascular devices
Domain
Medical Devices / Cardiovascular / Structural Heart Disease
Required skills
NPI/NPD, manufacturing operations, design transfers, process/equipment validation, supply chain strategy, DFM, Six Sigma, LEAN, cGMP, supplier development, MES deployment
Preferred skills
Injection molding, polymers, medical textiles, Nitinol, metals processing, process requirement specifications, supplier collaboration
Technologies
MES, 3P (Process, Product, People)
Responsibilities
Support operational transitions and design transfer deliverables; Partner with manufacturing sites to harmonize transfer plans and validation strategies; Lead integration meetings to inform stakeholders on progress and risks; Guide supply chain strategy development and cost assessment; Ensure robust characterization and validation activities; Identify and mitigate manufacturing risks; Drive continuous improvements in manufacturing processes; Ensure accuracy of manufacturing documentation and BOMs; Incorporate DFM and LEAN considerations into product designs; Track progress against operational metrics for commercialization.
Seniority
Senior, hands-on IC