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    System Engineer - Pittsburgh, United States - Resourcesys

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    Description

    ROLE :
    System engineer


    Location:
    Pittsburgh, PA


    Note:
    Any visa is fine

    Job Description

    Mandatory Skills:

    Systems Engineering for Electromechanical Medical Devices ISO 13485, ISO 14971, IEC 62304, Usability for Medical devices, Regulatory for Medical Devices Requirements Management, Jira, IEC and any Particular standards.

    Overall technical leadership and responsible for realization of full systems product release/life cycle management to ensure quality and compliance.
    Translation of user and business requirements into product requirements, high level product design, check and optimize integration and verification
    System decomposition and allocation of derived requirements down to HW/SW element and part level and related traceability.
    Trade-off of product/system design specifications and interfaces, determine feasibility of potential solutions, and leading technical & design reviews.
    Ensuring full Product Safety Risk Management in a regulation compliant manner KPI

    Product Quality

    Including but not limited to:
    Product Performance
    (Regulatory) Compliance
    Product Reliability
    Technical growth/leadership
    Stakeholder management
    On-time delivery to commitments

    Typically Required

    Master's degree or equivalent in Engineering and/or business discipline or alike experience

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