System Engineer

Pls share Candidates from Medical Devices Testing companies.

• 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

You are a part of: A team of highly skilled engineers that is focused on creating world class health care solutions.? Our focus on improving lives contributes to our amazing work environment and culture.

• 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

• 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