Job Description:
Manage Class II and 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.
Job Details:
- 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
- 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
- Effective communication with project stakeholders and management
- Communicate project status at defined intervals and meanings and escalate any concerns to the Supervisor and associated Management representatives.
Experience/skills required:
- BS in Engineering discipline or other relevant degree
- Industry experience of 4+ years
- Ability to coordinate across disciplines and integrate all aspects of the product.
- Experience in interventional medical device
Experience/skills preferred:
- Two years+ managing projects
- Verification and Validation experience
- Experience with design of experiments, statistical analysis techniques, and data analysis tools
- Strong background of delivery system development
- Skilled in product development processes and a general business understanding, preferably in the highly regulated medical device industry