Principal System Engineer - Westborough - Full Spectrum

    Full Spectrum
    Full Spectrum Westborough

    22 hours ago

    Description

    Principal Systems Engineer

    This position requires knowledge and experience in driving Systems Engineering on multiple engineering projects. The Principal Systems Engineer will have direct customer interface and leadership to manage a project and delegate tasks based on agreed client needs to other team members.

    • Safety Risk Analysis: Proficient with planning system risk analysis for complex medical devices that contain software, understand and identify potential harms and hazards leading to harm, ability to perform bottom-up failure analysis (FMEA). Practical experience applying risk over the lifecycle.
    • Project and V&V Leadership: Experience in iterative development, understand key tasks and typical medical device documentation. Proficient in V&V strategy, V&V planning software V&V approaches. Methodology in test development which includes test planning, design, and test case creation
    • Requirements Management: Practiced experience in developing and implementing requirement structure schema and hierarchy using requirement management tools. Proficient in requirement allocation and able correctly trace develop requirements trace matrices

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