System Engineer

System Engineer at Philips, Orlando, FL ( Oniste)

Interested candidate please share resume at [email protected]

Must Have: Medical Device, ISO 14971, IEC60601-1 Safety standard, IEC62336 EMC standard, DOORS

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 IEC60601-1 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 electrical 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

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