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System Engineer- Medical Device (Orlando)

System Engineer- Medical Device (Orlando)

DBSIOrlando, FL, United States
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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 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 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
  • Compensation : $50.00 - $60.00 per hour

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    Engineer Device • Orlando, FL, United States

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