Subject Matter Expert - Pune, India - Saaki Argus & Averil Consulting

    Saaki Argus & Averil Consulting
    Saaki Argus & Averil Consulting Pune, India

    2 weeks ago

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    Description
    Experience - 5+ YearsLocation -PuneMode - Hybrid

    Role

    - subject matter experts who has Proficiency in systems engineering and requirements management.
    KEY Skills Preferred

    • Understands Technical System Requirements well and effectively flows down them down into detailed Subsystem/Unit requirements.
    • Good understanding of software and hardware systems architecture.
    • Write Technical system requirements, review with a cross-functional team, and update in Doors (Requirement Management Tool)
    • Drive traceability between TSR to TSSR's and Risk files.
    • Good knowledge of ISO 14971, Risk management process
    • Basic or Expert knowledge about Regulatory standards and identifying applicable requirements to update System documents.
    • Basic knowledge about Electronics / Electrical / Mechanical and SW Design.
    • Basic knowledge of FMEA and drive DFMEA system level and drive down to sub-system level.
    • Verification of Medical device at system level - Test case writing, review, and execution.
    • Prepare documentation for regulatory submissions, ensuring compliance with applicable medical device regulations.
    • Understanding of System integration plan and test and reporting.
    • Excellent documentation and reporting skills.
    • Collaborative and able to work with cross-functional teams.
    • Good at coordination with External test labs for testing of applicable standards/requirementsTool: DOORs, JIRA, ClearQuest, HP ALM, Any PLM tools, Requirement management tools