Date Posted: July 06, 2017
Employment Type: Direct Hire
Job Id: 7749
Reporting directly to the President, this role is responsible for technically leading and driving new product development teams to deliver world changing products in the medical device field. The position has ownership for managing highly complex, technical projects encompassing large teams of engineering talent. This unique role partners with world class medical device companies to understand high level project goals, translate them into technical requirements and leads a team to invent, design, develop and transition products to manufacturing. The chosen candidate will be the key point of contact with highly technical, world class customer base.
- Leads a cross-functional engineering / technical team through the complete development cycle to invent, design, develop, and release to manufacturing medical devices, primarily medical therapeutic or diagnostic systems.
- Translates high level project goals into a comprehensive set of working requirements working with both internal and external project stakeholders.
- Creates comprehensive project plans that includes compliance with FDA guidelines and project clinical goals. Drives plans.
- Provides both high level technical and people leadership to project teams.
- Drives delivery of aggressive goals managing project schedule, cost and resources effectively.
- Interfaces with customers and manages the relationship to ensure crisp communication and alignment of objectives.
- Drives day to day project activity to achieve results including solving technical and other project challenges, managing resource conflicts, breaking down barriers, upholding high performance standards, and meeting commitments.
- Bachelor’s Degree in Engineering Discipline with a minimum of 15+ years leading product development teams solving challenging technical projects. Direct experience with complex electromechanical products with embedded software.
- Direct experience leading projects from initial concept through design and release. Must have experience successfully managing schedule, budget and project resources.
- Exceptional project management and communication skills – written and verbal – are essential.
- High energy, drive, commitment, self-initiative and perseverance are required with a demonstrated track record of personal technical accomplishments.
- Medical device background and experience with FDA regulations including premarket approval regulations, PMA’s, IDE’s and 510(k)’s strongly preferred.
- Domestic and International Travel Required.