System Engineer- Medical Device

Job Title: System Engineer
Location: Orlando, FL (Onsite)

Job Description:

· Systems Engineering in the medical area is what is needed and experience with these specs: · In depth knowledge performing risk management per ISO 14971 · In depth knowledge in developing and testing products to IEC Safety standard · In depth knowledge in developing and testing products to IEC62336 EMC standard

These are the next things to look for:

· 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 · DOORS and experience writing, reviewing requirements.

In this role, you have the opportunity to:

· Be a key contributor in the design and development of the Philips Clinical Applications and Devices Organization which includes MR Patient care a market leader in MR patient monitors which are the chosen solutions for the top 10 children's hospitals in the U.S.

You are responsible for:

· 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. · To succeed in this role, you should have the following skills and experience: · 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 IEC Safety standard · In depth knowledge in developing and testing products to IEC62336 EMC standard

Preferred 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

Compensation: $ $60.00 per hour

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