Senior Engineer, New Product Introduction
Core
Leads 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, supplier preparedness, and global product delivery for cardiovascular devices.
Domain
Medical device industry, structural heart disease, cardiovascular care
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
NPI/NPD, manufacturing operations, design transfers, process/equipment validation, supply chain strategy, DFM, Six Sigma, LEAN, cGMP, supplier development, business continuity planning
Preferred skills
Injection molding, polymers, medical textiles, metals processing (Nitinol), MES deployment, digital strategy, automation, mistake proofing
Technologies
MES, 3P (Process, Product, People)
Responsibilities
Support operational transitions and complete design transfer deliverables; harmonize transfer plans and validation strategies across manufacturing sites; 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/sale-up risks; drive continuous improvements in manufacturing processes; ensure accuracy of manufacturing documentation and execute playbooks for sourcing and transfer.
Seniority
Senior, hands-on IC