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This position is located in Littleton MA and reports into the Restorative Therapies Group (RTG) Contract Manufacturing (CM) Operations organization, as part of the Program Management Office (PMO). The Contract Manufacturing organization is responsible for the manufacturing, supply chain, and operational performance of RTG's Contract Manufacturing (CM) partners and Original Equipment Manufacturer (OEM) partners.
The Project Manager will be responsible for a portfolio of operations projects supporting Medtronic's O2 O-Arm X-Ray Imaging machine. This machine is designed and maintained in Littleton, MA and manufactured at one of Medtronic's CM Partners. The Operations project portfolio will consist of projects addressing Quality, Reliability, Manufacturing Improvements, and Cost. The Program Manager will be expected to oversee the performance of the portfolio of Operations projects, as well as own specific programs. This role will work within the Released Product Management (RPM) work structure, and ensure operations engineering resources are balanced and maintained across all RPM project to ensure operational success. The Program Manager will be expected to represent Operations on the Littleton site, including participation in CAPA Board, RPM Board, alignment of AOP budget & resource planning, and providing an operations focal point for critical escalations as-required.
Day in the life:
• Position requires a strong working understanding of Project Management skills including knowledge of project phases (Initiation, Planning, Execution, Control, Closure), and project management tools (theory of constraints, schedule development, budget development, work breakdown structure, risk management, stakeholder analysis/stakeholder management, conflict resolution).
• Responsible to own and drive project performance across the Operations project portfolio. This includes project planning, initiating, monitoring, tracking, and/or prioritizing engineering team's supplier excellence and sustaining engineering projects tasks, facilitating successful, on-time and within-budged execution.
• Project portfolio responsibilities include managing Operations-sponsored projects, as well as ensuring all Operations deliverables are met across the RPM project portfolio including programs supporting Quality, Regulatory, R&D and other critical functions.
• Responsible to work within the CM team strategy to identify new projects to support product and business needs identified by the team strategy, Annual Development Plan (ADP) and AOP targets.
• Responsible to work with Contract Manufacturing Engineering team (Supplier Excellence Engineering, and Sustaining Engineering) to drive project execution in support of AOP project plans. Work closely with a cross function team of site leaders, stake holders, and resources to evaluate, develop and manage the design and construction of engineering projects to ensure delivery of stated project goals.
• Set clear direction and management that aligns with defined Quality Management System (QMS) requirements, as well as business practices.
• Directs day to day activities for multiple work-stream teams through managing project plans, resources, status reporting, issue resolution, risk management, and accountability for deliverables across the CM operations project portfolio.
• Establish and maintain meaningful project metrics to reflect project health, and escalation of critical issues impacting project success.
• Ability to develop and manage product budgets, and work with project finance stakeholders to track project spending. This includes both expense budget and capital budget planning.
• Work within the site resource structure to ensure all projects have an accurate and up to date resource plan, with deep focus on cross functional resource demands. Ensure all resource plans are captured in local resource management tool, and consistent with AOP expectations and commitments.
• Act as the Operations focal point for interactions with our Contract Manufacturers (CM) partners and key stakeholders to drive all aspects project management.
• Works across the breadth of the Medtronic organization with functional leadership, peers and/or customers on all matters concerning project performance and project success metrics.
• Position requires a working understand of Process Development, Process Verification and Validation Master Planning including IQ/OQ/PQ, Test Method Validation, Manufacturing Transfer, and Supplier Controls.
• Drive technical rigor throughout the project management process to ensure appropriate quality and operations expectations are met through the lifecycle of the product/process. This may include component critical feature analysis, fault tree analysis to connect product requirement to manufacturing controls, helping to drive process capability metrics, ensuring sufficient component/material/process parameters are studied during characterization and verification/validation activity, and helping to ensure system assured compliance for all quality requirements.
• Ability to manage complex issues requiring evaluation of broad factors, exercises judgment within broadly defined practices.
• Incorporate measurements for manufacturing production performance into the project management process to ensure flawless transitions into manufacturing. This will include Key Performance Indicators (KPI) in the areas of Quality, Manufacturing, Continuity of Supply, Delivery, and Cost.
• Partner with all site functions (R&D, RPM, Product Design, Reliability, Design Verification & Validation, Product Design Assurance, Supplier Quality, Regulatory and other key functional areas to collaborate project requirements and drive successful outcomes.
• Customer focused in all interactions. Demonstrated ability to understand customer requirements and incorporate into business decisions.
Must Have: Minimum Qualifications
- Bachelor of Science in Electrical Engineering, Mechanical Engineering or similar related field and 5+ years of relevant experience
- Masters degree in Electrical Engineering, Mechanical Engineering or similar related field and 3+ years or relevant experience