He /she will be responsible for leading the design process, design reviews, requirements analysis, project timelines, problem solving and coordination of multiple subcontractors in a highly regulated environment.
Desired Skills and Experience:
• Bachelor degree in mechanical / electrical / biomedical / system engineering.
• 5+ years of cross functional program management / leadership experience. The project utilizes a core internal team and ~4 remote subcontractors from different functional areas. The role will include following a Product Development Process with formal stage gate reviews.
• Regulated Device Development experience. The ideal candidate will have experience with all phases of development of a medical device (ideally Point-of-care diagnostics).
• FDA/Design Control of Medical Devices. The ideal candidate will have knowledge/exposure to FDA requirements or Design Control for Medical Devices.
• In Vitro Diagnostic experience (advantage). The ideal candidate will have experience developing, submitting, and launching an In Vitro Diagnostic device into the US & EU markets.
• Excellent communication skills. Ability to effectively communicate and motivate a team of busy professionals. Ability to effectively communicate with and update senior leadership.