Senior Project Manager - NPI
Core
Leading manufacturing processes and supply chain systems to support the development and commercial launch of new medical device product programs, with a key focus on integrating additive manufacturing for a custom implant.
Role type
Senior Project Manager - New Product Introduction (NPI)
Builds
New medical device product programs and manufacturing processes
Domain
Medical Devices / Additive Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Project planning and execution, Cross-functional team leadership, FDA and international medical device regulations knowledge, Design for Manufacture (DFM), Capital acquisition strategy, Regulatory pathway alignment, Risk management
Preferred skills
Project management certification, Process validation experience, Six Sigma and lean methods
Technologies
Additive manufacturing systems
Responsibilities
Define project scope and manage budget for new product programs, Lead cross-functional teams including Quality, Production, and Logistics, Collaborate with manufacturing site leadership to introduce compliant processes, Drive capital acquisition and equipment validation, Develop communication strategies for stakeholders, Liaise with Regulatory Affairs for compliance