NPI Project Manager, Advanced Operations

About the Opportunity

Project Manager

Location: Tullagreen Facility in Cork

Responsibilities

• 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.

About You

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).

About Company

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.