Director/VP Operations

Challenging career opportunity for a seasoned medical device manufacturing manager.   You would join a growing implantable device company with recent US FDA Class III approval and 10 years of OUS marketing success with its innovative devices.  This expanding firm has created a role for a Director or VP of Operations to provide thoughtful leadership and overall strategic direction for the Manufacturing, Engineering, Strategic Sourcing, Material Supply Chain, Logistics, and Distribution functions.  

Primary Duties:

  • Provide strategic leadership in all manufacturing and production processes and projects, including organization-wide production plan development and execution.
  • Oversee Supply Chain Management, including outsourcing of implant/instrument components and processes as appropriate, in close coordination with Quality.
  • Sourcing of components and Bill of Materials development.
  • Development and implementation of manufacturing processes for all implants and instruments.
  • Coordination of Manufacturing and Quality efforts for development of effective inspection and data collection techniques and practices.
  • Integration of new products into CM environments, including process development.
  • Develop and execute overall manufacturing and scale-up strategy, with a focus on efficiency and cost.
  • Develop and execute budgets and operating plans for manufacturing, process development, facilities, and engineering staff and projects.
  • Hire and manage personnel, assign resources according to priority and project needs, and ensure their professional development. 
  • Manage production planning and communicate lead-times and capacity to the management team.
  • Participate in development and administration of company policies, long range goals, and objectives. 
  • Provide direction, focus, and visualization of activities in responsible departments to further the overall goals and objectives and monitor their progress.
  • Work collaboratively and cross-functionally with other key leaders in R&D, Finance, QA, Sales, Marketing.

Qualifications:

  • 15 years minimum medical device operations experience:
    • Strong preference for Class III implantable device manufacturing experience
    • Preference for depth in the manufacture of orthopedic devices
  • A history of career growth starting out on the plant floor, or coming up through manufacturing.
  • Knowledge of FDA QSR/GMP and ISO 13485 regulations/standards.

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