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 conditionsExperience with electronic requirement data management SW preferably DOORSMinimum five years engineering / R&D experience in a rigorous quality-focused environmentDOORS and experience writing, reviewing requirementsIn 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 engineeringExperience leading medical, or other regulated industry, product developmentExperience in leading groups to solutions for complex problemsExperience with deriving and simulating human interactions with devices and device use conditionsExperience with electronic requirement data management SW preferably DOORSMinimum five years engineering / R&D experience in a rigorous quality-focused environmentMinimum 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 disciplinesExcellent requirements and specification writing skillsDemonstrated deep understanding of US and international regulatory requirements for a heavily regulated productAbility to build and maintain effective cross-functional and cross-organizational relationshipsExcellent oral, written and presentation skillsIn depth knowledge performing risk management per ISO 14971In depth knowledge in developing and testing products to IEC60601-1 Safety standardIn depth knowledge in developing and testing products to IEC62336 EMC standardPreferred Requirements :
Understanding of US and international regulatory requirements for medical devices strongly preferredExperience developing reliability plansKnowledge of product development processes and best practicesKnowledge of verification and validation testing processesElectrical or Software development experience is a plusMaster's degree preferredCompensation : $50.00 - $60.00 per hour