Senior Project Manager - NPI
Core
Leading the implementation of manufacturing processes and supply chain systems to support the development and commercial launch of new product programs, with a key focus on integrating additive manufacturing technologies for a new custom implant.
Role type
Senior Project Manager - New Product Introduction (NPI)
Builds
New product programs (medical devices) from design development to commercial launch
Domain
Medical Devices / Manufacturing / Additive Manufacturing
Required skills
Project planning and management, Cross-functional team leadership, FDA and international medical device regulations knowledge, Design for Manufacture (DFM), Capital acquisition strategy, Risk management, Regulatory pathway alignment
Preferred skills
Project management certification, Process validation experience, Six Sigma and lean methods
Technologies
Additive manufacturing technologies
Responsibilities
Deliver manufacturing elements of new product programs including scope setting, planning, quality, budget, and supply management; Lead cross-functional teams (Quality, Production, Logistics, etc.) to achieve launch deliverables; Collaborate with manufacturing site leadership to introduce compliant processes; Drive capital acquisition strategy and support validation efforts; Develop communication plans for stakeholders; Liaise with Regulatory Affairs.
Seniority
Senior, hands-on IC