Summary:
Primary purpose of position is to manage the personnel, processes, equipment and procedures required to manufacture absorbable surgical products in compliance with applicable guidelines and requirements. This is accomplished by ensuring the functional area has the resources, training and information necessary to meet departmental and business objectives.
Responsibilities:
- Responsible for all aspect of manufacturing absorbable monofilaments, multifilament, tubing and film used in medical devices..
- Identify and implement an MRP system to track inventory.
- Responsible for developing schedules / plans to support both short-term and long-term business needs and objectives. Ensure optimization of production and capacity capabilities.
- Responsible for assuring the appropriate tools and resources are in place to support process improvement. Needs to assume the role of “mentor” and “change driver” for the department / area.
- Review and/or approve departmental documentation and written procedures such as SOPs, job routers, investigation reports, etc. Monitor and audit functional area(s) to ensure required documentation and procedures are up to date and consistent with current practices, processes and requirements.
- Provide guidance and mentoring to the manufacturing staff. Foster an environment in which responsibilities and results are achieved with the highest level of commitment to quality.
- Identify and oversee departmental training requirements and programs.
Basic Qualifications:
- BS/MS degree in an engineering discipline or 10 year equivalent experience.
- Minimum of 10 years experience in the manufacturing of medical devices.
- Previous leadership experience required.
- Extrusion experience preferred.