Program Manager

Great Medical Devices Program Management Opportunity!

Global leader in the development and production of extruded medical devices seeks a Program Manager to lead concept generation, design, development, prototyping and testing, validation, FDA and applicable regulatory approval through launch of plastic extruded medical devices.  The Program Manager will have full responsibility from concept to launch. 

Requirements

• B.S. in Mechanical Engineering or related discipline, MS or PhD preferred
• 10+ years experience in R&D of medical devices
• Extensive experience leading cross functional teams from concept to launch of medical devices
• Extensive experience in the design, development, testing, FDA approval and launch of extruded medical devices
• 510 (k) or IDE/PMA submission experience
• Expert level CAD, Solidworks

Key searchwords:  510K FDA extruded extrusion Solidworks CAD