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    System Engineer - Orlando, United States - Siri InfoSolutions

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    Description
    Job Description

    Job Description

    Title -

    System Engineer
    Location Orlando, FL (Onsite)

    Type :
    Full Time/Permanent

    Salary As per market standard


    Job Description:

    ELECTROMECHANICAL BACKGROUND
    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 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 IEC 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

    #J-18808-Ljbffr


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