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.
- 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.
- 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.