For a hi-tech company developing medical devices, with offices in the north Sharon.
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 NPI (New Product Introduction) related programs.
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 of NPI programs.
Define and meet operations objectives for NPI program: 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 NPI program plans and delivery methodologies
Lead cross functional NPI Operations 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 NPI 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 for NPI program.
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)
Extensive experience leading a complex project/program including financial accountability including strong preference for PMP certification
Product/Process technical expertise 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 3 related disciplines (with knowledge of all) such as:
Product software and hardware development
Supply chain planning/capacity planning for launch
Sourcing including component qualification
Quality engineering including new product
Biotech/medical, High Tech
Medium (50 - 150)