Summary:
This position requires hands-on individual with fiber extrusion and processing experience within the medical device industry. The individual must be a self starter, able to work with minimal supervision and must be goal oriented.
Duties:
- The development and commercialization of novel new biopolymer medical products.
- The development of manufacturing processes and scale-ups into commercialization.
- The development of equipment through proof of concept and implementation in manufacturing.
- Responsible for the assembly, maintenance, set up and operation of melt extrusion equipment.
- Development of extrusion processes to produce monofilament / multifilament for use in medical devices.
- Development of medical textile processes and preparation of samples for various studies.
- Test material using rheometry, melt flow indexing, tensile and fatigue.
- Analyze test data and reports to determine conformance to requirement.
- You will write, and execute test procedures and SOP’s.
- Research, develop, and evaluate materials, processes and/or equipment.
- Conduct feasibility studies to verify capability and functionality.
- Familiar with all aspects of quality systems, CAPA, QSIT, FMEA, QSR.
Experience:
5+ years minimum experience in the development of medical fiber extrusion with knowledge of validation and design control
Education:
PhD degree in engineering or chemistry is preferred. Combination of education and experience will be considered.