Systems Engineer-Medical Domain

Job Summary:

• Overall technical leadership and responsibility for 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.

Responsilities:

• 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 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.

Requirements:

• Understanding of US and international regulatory requirements for medical devices 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.
• Master's degree preferred.