Principal Engineer, NPD
Core
Lead manufacturing process optimization, design control, and equipment engineering for transcatheter heart valve devices to support commercialization.
Role type
Senior IC manufacturing engineering lead (medical devices)
Builds
Transcatheter heart valve devices (TAVR) for structural heart disease treatment
Domain
Medical device manufacturing / Structural heart disease
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
manufacturing process optimization, design control, process validation (IQ/OQ), equipment engineering, tooling design, risk management (SCRR/MRR), Lean methods, project management, technical documentation, tolerance stack-up analysis, root cause investigation
Preferred skills
CAD, MS Office Suite, cleanroom operations knowledge
Technologies
TOPP technology, Project Plan, pFMEA
Responsibilities
Develop complex manufacturing documentation (drawings, SOPs, routers), execute process qualifications and validations, lead build strategy and technical support for pre-DV/DV phases, drive design improvements for manufacturing ease, oversee manufacturing support tasks and supervise technicians, analyze manufacturing and compliance issues (CAPA, non-conformance), redesign equipment and fixtures to improve processes
Seniority
Senior, hands-on IC with team lead responsibilities
