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    Senior System Engineer - Pittsburgh, United States - Cynet Systems

    Cynet Systems
    Cynet Systems Pittsburgh, United States

    4 weeks ago

    Default job background
    Description
    Job Description:

    Pay Range $80000yr - $85000yr
    • 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:
    • 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 business discipline or a like experience.
    Skills:
    • Systems Engineering for Electromechanical Medical Devices, InCose certification ISO 13485, ISO 14971, IEC 62304, Usability for Medical devices, Regulatory for Medical Devices Requirements Management, Jira, IEC and any Particular standards.
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