Overall technical leadership and responsibility for the realization of a new product release and sustaining activity.
Translation of user requirements, requirements management, top-level design, feasibility of potential solutions, decomposition of derived requirements
Systems design/architecture and Integration oversight.
Support for NPI efforts that create value for Clinical Applications and Devices Organization through innovation and design, while delivering high-quality engineering solutions.
Technical liaison to the program
Defect/Risk management and Design Reviews
Requirements & Skills:
BS degree in engineering
Experience leading medical, or other regulated industry, product development
Experience in leading groups to solutions for complex problems
Experience with deriving and simulating human interactions with devices and device use conditions
Experience with electronic requirement data management SW – preferably DOORS
Minimum five years engineering / R&D experience in a rigorous quality-focused environment
Minimum three years experience in a Systems Engineering role, or a role having overall systems responsibility involving electrical (analog and digital), mechanical, firmware, and software development disciplines
Excellent requirements and specification writing skills
Demonstrated deep understanding of US and international regulatory requirements for a heavily regulated product
Ability to build and maintain effective cross-functional and cross-organizational relationships
Excellent oral, written, and presentation skills
In-depth knowledge of performing risk management per ISO 14971
In-depth knowledge in developing and testing products to IEC60601-1 Safety standard
In-depth knowledge in developing and testing products to IEC62336 EMC standard
Understanding of US and international regulatory requirements for medical devices is strongly preferred
Experience developing reliability plans
Knowledge of product development processes and best practices
Knowledge of verification and validation testing processes
Electrical or Software development experience is a plus
