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19000DI8 Requisition #
Careers that Change Lives:
Engineers and Scientists create our market-leading portfolio of innovations. Join us to make a lasting impact. Help bring the next generation of life-changing medical technology to patients worldwide. 
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.
This position is the single point of contact for all operations aspects of new product development to a core product development team.  The candidate will own and ensure overall project execution with respect to schedule, budget, and compliance to internal quality requirements.  The Core Team Operations Representative (CTOR) leads a cross-functional operations team comprised of Manufacturing, Supply Chain, Sourcing, Medical Packaging, Sterilization, and Pharmaceutical functions.


Program Management
Meet following deliverables through cross-functional collaboration
• Quality System Compliance to support Good Manufacturing Practice (21 CFR 211) and Quality System Regulations (21 CFR 820)
• Product builds to meet program requirements
• Business deliverables defined by Product Development Process (PDP)
• End to end Operations schedule and technical risk burn down
• Design Transfer to Operations and Released Products Engineering (RPE)
             Identify, document, and manage program resources and schedule
• Develop and maintain detailed project schedule aligned to PDP – Design Phase expectations
• Lead extended cross-functional operations team to ensure on-time and on-budget performance
• Ensure alignment between operations and core team functions
Secure required resources and expense funding

Voice of Operations
Champion manufacturing strategy and sourcing strategy for program
• Ensure alignment between Operations and New Product Development Program
• Lead decision making for facility locations, make-buy decisions (Internal vs. CM/OEM), business continuity, etc.
• Define and meet operations objectives:  Labor, Burden, Material, Cycle Time, Capacity, First Run Yield, Cumulative Yield, Process Capability/Ppk, etc.
Ensure Design for Reliability and Manufacturing (DRM) is consistently and rigorously applied
Align program needs to process roadmaps for Vertically Integrated Suppliers (VIS), High Volume Facilities (HVF), and Original Device Manufacturer (ODM) / Contract Manufacturer (CM)
Ensure timely and thorough updates at various levels of the organization (Program Core and Extended Teams, Senior Management, Executive Management)
Polished communication skills including effective public speaking and presentation
Commercialization Readiness
Collaborate with Global Supply Chain (GSC) to drive:
• SIOP to Master Schedule definition
• Capacity/launch planning and execution
• Phase In / Phase Out strategy development and execution
• Clinical build readiness and execution, Process Qualification Activities
• Post design assurance change tracking implementation decisions
• Contract Negotiations 

Indirect People Management & Development
Recognize teams and individuals for exceptional performance
Provide candid performance feedback to team member’s direct manager
Actively coach and mentor extended operations team

Responsibilities may include the following and other duties may be assigned.

  • Responsible for planning, initiating, monitoring, tracking and/or prioritizing engineering team's product development programs or projects and facilitating successful, on-time and within budget execution.
  • Sets clear direction and management that aligns with defined practices and policies.
  • Works closely with cross-functional teams to evaluate, develop and manage the design and construction of engineering projects to ensure delivery of a product or computer-based system through the design process, and into a finished state for external customers.
  • Directs day to day activities for multiple work-stream teams through managing project plans, resourcing, status reporting, resolving issues, identifying project risks and accountability for deliverables across multiple functional organizations.
  • Establishes meaningful metrics.
  • Responsible for project performance, risk management, administration, financial management, budgeting, capital planning, forecasting and issue resolution.
Must Have: Minimum Requirements

  • Bachelors degree required
  • Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience
Nice to Have:
Proven Operations leadership or Program Management success
Demonstrated ability to build collaborative relationships across organization, partner with businesses, and geography boundaries
Demonstration of clear and concise written and verbal communication
Strong business and financial acumen
Able to travel 20-30% (air and ground, domestic and international)
Demonstrated experience with Quality Management System compliance
Strong Project Management and process-mapping skills and experience
Master’s in Business Administration (MBA) or Engineering Management 
Experience with Pharma and Combination Medical Products  
Medical device product development experience and a strong understanding of FDA, ICH and IEC standards
Strong understanding of Design for Reliability and Manufacturability (DRM), Lean, Six Sigma, or Chemistry, Manufacturing & Controls concepts and application across entire product lifecycle
DFSS or Six Sigma Green Belt / Black Belt Certified
PMP Certified

About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.


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