Senior Project Manager - NPI

About the role

The Senior Project Manager – NPI will lead the implementation of manufacturing processes and supply‑chain systems for new product programs, ensuring timely, on‑budget delivery and compliance with medical‑device quality standards.

Key responsibilities

• Define scope, plan and manage the manufacturing element of new product programs, covering product quality, budget, supply management and Design for Manufacture.
• Lead a cross‑functional team (Quality, Production, Packaging, Logistics, Finance, Engineering, HR, EH&S, etc.) to achieve launch deliverables.
• Collaborate with site leadership during design development to introduce compliant manufacturing processes on schedule and within budget.
• Drive capital acquisition strategy, secure approvals, support contract negotiations and oversee installation, qualification and validation.
• Develop communication plans to update Commercial and Operational stakeholders and liaise with Regulatory Affairs to align with regulatory pathways.

Required profile

• Bachelor’s degree in engineering or science or equivalent.
• Proven project‑management experience in a regulated industry with knowledge of FDA and international medical‑device regulations.
• Strong analytical, problem‑solving and risk‑management abilities.
• Ability to lead, motivate and influence cross‑functional teams on moderate‑complexity projects.

Required skills

• Six Sigma methodology
• Lean methods
• Process validation
• Project management (certification preferred)