Oversee and manage design-controlled product development efforts including definition of proper and testable product requirements, definition of product development milestones, conducting design reviews, and rigorous testing analysis in support of verification and validation activities.
Manage and lead teams of non-direct reports
Create and manage project scope, schedule, and budget
Monitor and maintain awareness of new and current product regulations and standards
Manage a project within standardized methods and project models
Ensure the timely release of critical deliverables within the project
Schedule and lead meetings to coordinate inter-departmental project activities; including those necessary to resolve project issues
Ensure all aspects of the project are in compliance to internal procedures
Understanding of group dynamics to influence team members
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.
