Please review BASIC QUALIFICATIONS.  If you meet BASIC QUALIFICATIONS submit your resume for review and we will reach out to you for a follow up call. 

This role is available at multiple LOCATIONS:

RICE CREEK, MN

JACKSONVILLE, FL

IRVINE, CA

CAREERS THAT CHANGE LIVES Impact patient outcomes. Come for a job, stay for a career.

This position represents Operations on Development projects as a CTOR (Core Team Operations Representatives) and provide leadership to an extended project team comprised of individuals from Manufacturing Operations, 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 Senior 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.

BASIC QUALIFICATIONS/MUST HAVE'S

• Bachelor’s degree in Science, Engineering and 7+ years of relevant experience or Masters degree and 5+ years or relevant experience in EACH of 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 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

• Great Communication Skills (Verbal, Written, and Presentation Skills)

• 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

• For People Leaders ONLY:Remote team People Leadership or remote start-ups (line transfers; remote working) including peaks of high travel

A DAY IN THE LIFE

• Manages subordinate supervisors and/or experienced professionals who exercise latitude and independence in assignments. 

• 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. • May have budget or P&L accountability for a department, function or geography. Strive for continuous improvement and consistency in deliverables. • Proposes modifications to functional operating policies and day-to-day processes. Problems and issues faced are complex, difficult and undefined, and require detailed information gathering, analysis and investigation to understand the problem. • Communicates with internal and external customers and vendors regarding ongoing operations. Uses information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties. May interact on issues that have externally shared objectives. • 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. • Responsibility for all Operations activities and deliverables in product development planning and execution. • Responsible for developing, communicating, and documenting project strategies and plans including operations budget and detailed schedule creation and maintenance • Overall value stream development and process responsibility from technology through market release. • Champion and document the Voice of Operations. • Ensure the quality policy/system is planned, understood, implemented and maintained. • Manages one or more developed or mature programs with well-defined program plans and delivery methodologies • Ensure Operations aspects of Quality System Compliance, Design History File, and Regulatory Submissions documentation • Coordinate Development builds • Lead the manufacturing and supply chain schedule risk burn down • 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. • Define and meet operations objectives: Labor, Burden, Material, Cycle Time, Capacity, First Run Yield, Cum Yield, Process, etc

• 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