Project Manager – New Product Introduction (Medical Devices)

About the role

We are looking for an NPI Project Manager with a strong background in medical device engineering and manufacturing to lead new manufacturing process implementations. This customer‑facing position manages projects from initial engagement through first production, ensuring technical rigor, regulatory compliance and successful delivery.

Key responsibilities

• Lead the full project lifecycle from customer engagement through initial production, aligning all objectives.
• Act as a hands‑on technical lead, contributing to manufacturing strategy and resolving issues.
• Develop and maintain detailed project plans, schedules, and risk‑mitigation strategies.
• Drive execution by removing technical and operational roadblocks.
• Manage and track critical activities, directly involved in key technical deliverables.
• Proactively identify and resolve issues impacting timeline, cost, or manufacturability.
• Serve as the primary technical point of contact for customers.
• Lead technical discussions, provide updates, and resolve design or process challenges.
• Translate product requirements into actionable manufacturing plans.
• Evaluate designs, materials, and processes for manufacturability, scalability, and compliance.
• Lead development of new manufacturing processes, tooling, and production workflows.
• Lead or contribute to process validation activities (IQ/OQ/PQ) and ensure production readiness.
• Ensure all technical requirements are clearly defined and implemented.

Required profile

• Bachelor’s degree in Engineering (Mechanical preferred).
• 3–5 years hands‑on experience as a senior engineer in R&D, process development or manufacturing within medical device or regulated environments.
• 1–2 years project management experience in a cross‑functional setting.
• Demonstrated experience in process development, NPI, and manufacturing implementation.
• Ability to work independently on technical challenges.
• Strong understanding of process validation (IQ/OQ/PQ), medical device quality systems, and design for manufacturability.

Required skills

• Process validation (IQ/OQ/PQ)
• Medical device quality systems
• Design for Manufacturability (DFM)
• MS Project
• Smartsheet
• LEAN manufacturing
• Continuous improvement tools