This position represents Operations on new product introduction project core teams as a CTOR (Core Team Operations Representative) and provide leadership to an extended project team comprised of individuals from Manufacturing Operations (software and hardware), Supply Chain Planning, Category Management, Sourcing, Contract Manufacturers / OEM, Supplier Quality, and other functions as needed to drive successful development and commercialization of new products. This position is responsible for the overall operations aspects including value stream selection, planning, execution and successful implementation of activities in the development and introduction of new products. The Program Manager has the responsibility to ensure that the voice of operations is properly captured, and all team commitments and project contract metrics are met and communicated in a timely manner.
A Day in the Life
Responsibility for all Operations activities and deliverables in product development planning and execution.
Overall value stream development and process responsibility from technology through market release (ID2MR).
Represent Operations and manufacturing priorities at the Core Team level ensuring key operations elements are part of the program plan and executed.
Responsible for identifying, evaluating, and communicating Operations plans to include Operations trade-offs to appropriate Stakeholders.
Lead the manufacturing and supply chain schedule risk burn down. This includes accountability in supplier selection, contract agreements, costing structure, and order fulfillment for on time delivery.
Define and meet operations objectives: Labor, Burden, Material, Cycle Time, Capacity, First Run Yield, Cum Yield, Process Ppk, etc…
Manages one or more developed or mature programs with well-defined program plans and delivery methodologies
Lead cross functional teams including Design, Manufacturing Operations, Supply Chain Planning, Category Management, Sourcing, Contract Manufacturers / OEM, Supplier Quality, through the product development process to ensure successful completion of development projects and business goals.
Provides tactical and / or operational leadership and coaching. Receives assignments in task and objective oriented terms.
Establishes operational plans and implements policies and strategies. Decisions impact program schedules, customer satisfaction levels, or allocation of time, material resources, expenditures and funds.
Responsible for developing, communicating, and documenting project strategies and plans including operations budget and detailed schedule creation and maintenance
Champion and document the Voice of Operations.
Ensure the quality policy/system is planned, understood, implemented and maintained.
Ensure Operations aspects of Quality System Compliance, Design History File, and Regulatory Submissions documentation
Coordinate Development builds
Ensure alignment between operations and core team
Champion manufacturing strategy and sourcing strategy for program
Lead decision making for facility locations, make-buy decisions, business continuity.
Ensure Design for Reliability and Manufacturing (DRM) is consistently and rigorously applied
Facilitate launch build planning, capacity planning and execution and Commercialization Readiness activities
Indirect People Management & Development
Actively coach and mentor extended operations team
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Bachelor’s degree in Science, Engineering and 7+ years of relevant experience or Masters degree and 5+ years or relevant experience in the following areas:
Experience in new product OR new process development including launch (R&D optional)
Project Management: Extensive experience leading a complex project/program including financial accountability including strong preference for PMP certification
Product/Process technical expertise include including Qualifications (i.e. Validation including IQ, OQ, PQ activities; CPAP or related)
Manufacturing Engineering experience
Experience with Design for Manufacturability/DRM/DFSS or similar methodology
Experience or extensive knowledge of at least 2 related disciplines (with knowledge of all) such as:
1. Product software and hardware development
2. Supply chain planning/capacity planning for launch
3. Sourcing including component qualification
4. Quality engineering including new product
5. Manufacturing supervisor/manager
Leadership through influence in matrixed organization and ability to work well in a team environment including cross-culture
Experience in medical device or highly regulated industry
Proficiency in Communication Skills (Verbal, Written, and Presentation Skills) across multiple levels to peers and leadership.
Business acumen and understanding of operations costing (LBM, OPC, Inventory deferrals, capital project management, etc.)
Ability to strongly advocate for and represent Operations to a cross functional team related to project and business needs.
Fluent in Hebrew and English is preferred