We are searching for a Process Development Manager for a rapidly growing medical devices company. This exciting company, in the cardiovascular space, is expected to go public next year. It has several diagnostic platforms in development.
The Process Development Manager will be responsible for the design, development, implementation, and control of new and improved manufacturing processes. The Process Development Manager will provide daily support of products, processes, materials and supplier management, and equipment for new and sustaining products.
Requirements for the Process Development Manager:
- Bachelor's Degree in engineering preferably mechanical or biomedical.
- 8+ years' medical device experience in process/manufacturing engineering role.
- Experience in Design for Manufacturing (DFM), Lean Manufacturing, Design of Experiments (DoE), technology/process transfer experience, product/process failure mode and effects analysis (FMEA), and problem solving methodologies.
- Understanding of medical device design controls / quality systems and product development processes
- Experience in a regulated environment; preferably medical device
- Solid knowledge of FDA regulations and interpretation of FDA regulations, guidelines and policy statements.
- Excellent verbal/written communication skills
- Ability to organize, records, and implement procedures
- Six Sigma training, certification preferred
- Experienced in CAD, preferably SolidWorks
Occupational Category: 17-2141 Mechanical Engineers