Sr. Systems Engineer - Pittsburgh, United States - Intellectt Inc

    Intellectt Inc background
    Upper Management / Consulting
    Description

    Title: Sr. Systems Engineer

    Location: Pittsburg, PA

    Job Description:

    Mandatory 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.
    • 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.