Systems Engineer-Medical Domain

Job Title

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.

Responsibilities

• 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.