Senior Project Manager - NPI

About the role

Stryker is looking for a Senior Project Manager (NPI) based in Anngrove, Cork, working in a hybrid or onsite capacity. The role leads the implementation of manufacturing processes and supply chain systems to support the development and commercial launch of new product programs, within a medical device quality management system. It focuses on integrating additive manufacturing technologies to launch a new custom implant, and involves close work with Commercial and Operational leadership.

Key responsibilities

• Deliver the manufacturing element of new product programs, covering scope setting, project planning and management, product quality, budget and supply management, and DFM (Design for Manufacture).
• Lead a cross-functional team of professionals from Quality, Sterilization, Production, Packaging, Labelling, Materials, Logistics, Finance, Industrial Engineering, HR, Process Engineering, Facilities and EH&S, and take overall responsibility for the teams and their deliverables.
• Work with manufacturing site leadership during design development so that new manufacturing processes are introduced into production on time, within budget and in line with plant strategy, meeting all quality management system requirements.
• Drive capital acquisition by defining total CAPEX and OPEX, securing internal approvals, supporting contract negotiations and ensuring timely installation, qualification and validation.
• Create a communication plan to share project status with Commercial and Operational stakeholders.
• Liaise with Regulatory Affairs to align the project strategy with the required regulatory pathway.

Required profile

• Bachelor's degree in engineering or science, or equivalent.
• Essential: PM experience in engineering or project work in a regulated industry.
• Ability to plan, prioritize, multitask and organize a multi-disciplinary team to deliver project outcomes.
• Knowledge of FDA and international medical device regulations.
• Preferred: project management certification from an accredited body, process validation experience, and experience delivering results through Six Sigma and lean methods.

Required skills

• FDA and international medical device regulations
• Risk management
• Process validation (preferred)
• Six Sigma and lean methods (preferred)

The position is permanent and full-time, with about 10% travel.