Work Flexibility: Hybrid or OnsitePosition Summary This position is responsible for managing (scope setting, project planning, and execution) the implementation of all manufacturing processes and associated supply chain systems to support the development and commercial launch of new product programs on time, within budget, and to the required performance requirements.
Working within the medical device quality management system, this leader manages a cross-functional team of professionals promoting collaboration and alignment within the team while simultaneously interfacing with both Commercial and Operational leaders to maintain organizational alignment through stakeholder management.
This is an individual contributor role that requires the use of judgment in applying professional expertise and is expected to work independently with minimal supervision.What you will doDelivery 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 5 years for Senior 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).Travel Percentage: 10%