Process Development Engineer

We are searching for a Process Development Engineer 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 Engineer will work to design, develop, and implement, new and improved manufacturing processes for the company's control console program. The Process Development Engineer will provide daily support of products, processes, materials and supplier management, and equipment for new and sustaining products.

Requirements for the Process Development Engineer:

• Bachelor's Degree in engineering preferably mechanical or biomedical.
• 3+ 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.
• Experience with validation/verification of processes/inspection methods for manufacturing (IQ, OQ, PQ)
• 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