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    Director of Engineering - Boston, United States - CM Medical Recruitment

    CM Medical Recruitment
    CM Medical Recruitment Boston, United States

    2 weeks ago

    Default job background
    Upper Management / Consulting
    Description

    CM Medical have partned with a neurostimulation start-up that is seeking a Director of Engineering for their Boston, MA office.

    This role involves leading engineering efforts, guiding their prototype device into clinical manufacturing.

    Responsibilities:

    • Provide mentorship to engineers in technical and professional growth.
    • Strategise, assess, and advance our medical device products.
    • Evaluate system architecture and propose enhancements.
    • Oversee integration of all technical aspects, including hardware, firmware, and software.
    • Define design verification scope and automated testing, supporting verification and validation.
    • Manage Design History File (DHF) documentation and regulatory submissions.
    • Supervise risk register and lead risk mitigation efforts.
    • Ensure device adherence to requirements and specifications, employing validated processes.
    • Lead manufacturing enhancement initiatives and maintain supplier relationships.
    • Drive system-wide troubleshooting and root cause analysis.
    • Devise strategies for monitoring device reliability and performance.

    Experience

    • Bachelor's degree in engineering or related field.
    • Experience in medical device industry (Class III).
    • Familiarity with FDA Quality Systems Regulations and ISO 13485; exposure to ISO-14708 is advantageous.
    • Strong leadership abilities, excellent communication skills, and adept problem-solving capabilities.
    • Ability to manage multiple tasks, meet deadlines, and enforce accountability.
    • Understanding of mechanical, electronic, and software design principles.
    • Proficiency in navigating designs from prototype to clinical manufacturing.

    How do I apply?

    If you like what you've read so far, hit the apply button or send your CV to

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