Senior Project Manager - NPI

This position is responsible for leading the implementation of all manufacturing processes and associated supply chain systems to support the development and commercial launch of new product programs. The role encompasses scope definition, project planning, and execution—ensuring delivery on time, within budget, and in alignment with performance requirements.

Operating within a medical device quality management system, this leader will manage a cross-functional team, fostering collaboration and alignment across functions. The role also requires close engagement with both Commercial and Operational leadership to ensure organizational alignment through effective stakeholder management.

A key focus of this position is the integration of additive manufacturing technologies, enabling cross-functional collaboration to support the launch of a new custom implant. This initiative will serve as a foundational step toward future divisional applications.

• Delivery of the manufacturing element of new product programs, with specific focus on scope setting, project planning and management, product quality, budget management, product supply management, and DFM (Design for Manufacture).

• Provides strong, capable leadership to the project team encompassing key professionals from Quality, Sterilization, Production, Packaging, Labelling, Materials, Logistics, Finance, Industrial Engineering, HR, Process Engineering, Facilities & EH&S to ensure new product launch deliverables are achieved. Assumes overall responsibility for assigned teams and operational deliverables.

• Collaborates closely with leadership at the manufacturing site during the design development phase to ensure that all new manufacturing processes are introduced into production compliantly, on time, within budget, are operationally successful, and in alignment with the broader plant manufacturing strategy. Ensures all required quality management system deliverables are met by the team to effectively transfer the product into commercialization from the design development phase.

• Drives capital acquisition strategy through determining total capital expenditure and operational expense, acquiring internal approvals, supporting contract negotiations, and ensuring timely installation, qualification, and validation efforts.

• Develop a comprehensive communication plan and strategy to convey project status updates to stakeholders at both Commercial and Operational business forums.

• Liaises with Regulatory Affairs to ensure the project strategy is aligned with the required regulatory pathway and appropriate regulations are met.

• Bachelor’s degree in engineering or science discipline or equivalent required.

• PM role experience in engineering/project in a regulated industry essential. Has demonstrated the ability to successfully plan, prioritize, multitask and organize a multi-disciplinary team(s) to successfully achieve project deliverables.

• Has applied knowledge of FDA & International medical device regulations.

• Ability to lead, motivate, and influence a cross-functional team on moderate complexity projects that do not report directly to this position.

• Excellent analytical and problem-solving skills including risk management experience.

Preferred:

• Project management certification through an accredited organization (preferred).

• Experience in process validation

• Experience with delivering results through Six Sigma and lean methods

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