NPI Project Manager, Advanced Operations

Project Manager

Location: Tullagreen Facility in Cork

Position Summary

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 includes defining scope, planning projects, and executing deliverables—ensuring outcomes are achieved on time, within budget, and in accordance with performance and quality standards.

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

A primary focus of this role is the integration of additive implant technologies into downstream manufacturing activities to enable the successful launch of a new implant. As this initiative is in its early stages, the selected individual will have the opportunity to define the strategic direction and establish the foundational framework for future divisional applications. Serving as the main Downstream Project Manager for this new additive program, this individual will play a critical role in shaping the program’s success and long-term impact.

What you will do

• 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.

What you will need

•  Bachelor’s degree in engineering or science discipline or equivalent required. Project management certification through an accredited organization (preferred).
• Minimum of 4 years for PM role in engineering/project experience 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.
• Experience in process validation preferred.
• Experience with delivering results through Six Sigma and lean methods is preferred.
• High level of PC skills required (MS Excel, PowerPoint, and MS Project).

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