System EngineerPhilips, Orlando, FL (Oniste)Must Have: Medical Device, ISO 14971, IEC60601-1 Safety standard, IEC62336 EMC standard, DOORSSystems Engineering in the medical area is what is needed and experience with these specs:In 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 standardThese 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 requirements.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 requirementsSystems 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 programDefect/Risk management and Design ReviewTo 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 RequirementsUnderstanding 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 preferredDisclaimer: E-Solutions Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. We especially invite women, minorities, veterans, and individuals with disabilities to apply.
EEO/AA/M/F/Vet/Disability.”