System Engineer

Responsibilities:

• 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:

• 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.

Job Type: Contract

Experience level:

• 3 years

Schedule:

• Day shift

Ability to Relocate:

• Orlando, FL: Relocate before starting work (Required)

Work Location: In person