Manage Class III R D projects focused on the creation of new products and improvements to existing products through an understanding of the underlying science and technology.
Lead the project through all phases of the project, from Concept Development to Product Launch- Develop project timelines, assemble required project teams, track the schedule and deliverables, and maintain effective communication throughout the project.
Requirements: BS in Engineering discipline or other relevant degree
Skilled in product development processes and a general business understanding, preferably in the highly regulated medical device industry
Industry experience of 5+ years including two years managing projects
Ability to coordinate across disciplines and integrate all aspects of business as they impact development projects including negotiation of scope, roles and responsibilities, specifications, timelines, and resources - up, down and, across the organization
Verification and Validation experience with FDA-cleared devices
Experience with design of experiments, statistical analysis techniques, and data analysis tools
Prior experience in interventional medical device is necessary
Prior history working in an FDA regulated development environment; specifically ISO 13485
This position is open to all candidates.
