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    System Engineer - Orlando, United States - Katalyst Healthcares and Life Sciences

    Katalyst Healthcares and Life Sciences
    Katalyst Healthcares and Life Sciences Orlando, United States

    1 week ago

    Default job background
    Description
    Responsibilities:
    • 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.
    • bility 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
    • In depth knowledge in developing and testing products to IEC Safety standard.
    • In depth knowledge in developing and testing products to IEC62336 EMC standard.
    Requirements:
    • 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.
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