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Engineering Project Manager

Company Name:
DEKA Research & Development
Position Type:
Full-time
Responsibilities
Lead a cross-functional engineering team through the complete development cycle to invent, design, develop, and release to manufacturing medical devices, primarily medical therapeutic or diagnostic systems
Manage constrained schedule, budget, and resources to achieve aggressive project goals
Translate high-level project input into a comprehensive set of requirements working with both internal and external project stakeholders
Drive the technology development to ensure there is a solid, protectable technology base to do the job
Lead customer interaction on a daily basis
Layout comprehensive project plan that includes compliance with FDA guidelines and project clinical goals; continue to monitor and re-plan as necessary
Drive the day to day activity to get the job done; solving problems, managing resource conflicts, breaking down barriers, upholding high performance standards, meeting commitments
Desired Qualifications
Engineering degree with at least 10 years of work experience in a product development environment, including leading a project through the design / release process
Direct experience leading a product development team - including schedule, budget, and resource management responsibility
Demonstrated track record of personal technical accomplishments
Highly technical / engineering project management background required
Medical device background and experience with FDA regulations including premarket approval regulations, PMA's, IDE's and 510(k)'s a big plus
Desired Characteristics
High energy
Self motivated & passionate
Very technically competent
Able to challenge and make

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