System Engineer - Orlando, United States - DKMRBH Inc

Description

Responsibilities:
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 ReviewsYou 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 / RandD 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 IEC 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 preferred#J-18808-Ljbffr