Senior Project Manager - NPI
HybridCork, Munster, Ireland
Job Summary
Lead the implementation of manufacturing processes and supply chain systems for new product programs, managing scope definition, planning, and execution to ensure on-time, on-budget delivery. Direct a cross-functional team across Quality, Production, Engineering, and Finance to introduce compliant manufacturing processes while driving capital acquisition strategies and operational expense management. Ensure all quality management system and regulatory pathway deliverables are met from design development through commercialization, utilizing Six Sigma and lean methods. Collaborate closely with Commercial and Operational leadership to align stakeholder expectations and support the launch of custom implant technologies.
Required Qualifications
- Bachelor's degree in engineering or science discipline
- PM role experience in engineering/project in a regulated industry
- Demonstrated ability to successfully plan, prioritize, multitask and organize a multi-disciplinary team(s) to successfully achieve project deliverables
- 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
- 10% travel
Desired Qualifications
- Project management certification through an accredited organization
- Experience in process validation
- Experience with delivering results through Six Sigma and lean methods
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