• Senior Systems Engineer

    March 7, 2017 • Careers

    Senior Systems Engineer

    Location: CSA Medical Headquarters, Lexington, MA

     

    Job Description

    The Systems Engineer will participate in the development of CSA Medical’s next generation CryoSpray Ablation consoles and accessories, including preparation of

    documentation required for the quality system.

    Duties and Responsibilities

    This may include but is not limited to the following:

    • Design and develop electrical and mechanical new features and improvements of consoles.
    • Generate and update design input and risk management documents.
    • Oversee design, development and design transfer of externally developed system components.
    • Support system-level design verification and validation.
    • Generate and update design input and risk management documents.
    • Devise and perform analysis and testing of design outputs to justify design input requirements and design decisions.
    • Analyze design changes in the context of design input requirements and determine and defend re-verification plans.
    • Support the compilation and submission of regulatory filings.

    Skills & Competencies

    Position requirements, qualifications and experiences:

    • B.S. in engineering discipline (e.g. Electrical / Mechanical / Biomedical / Software), M.S. preferred.
    • 7+ years’ experience in medical device product development, including FDA regulated devices covered by 510(k) or PMA.
    • Experience with mechanical, electrical and software systems required, experience with cryogenic applications preferred.
    • Experience with system level verifications involving software.
    • Proficient in comprehending or producing technical design documents.
    • Experience following detailed test protocols as well as recording results.
    • Flexibility and adaptability to change.
    • Extremely self-motivated and goal-oriented.
    • Excellent communication skills to support working independently and with a team.
    • Proficient with Microsoft Office Software products.

    How to Apply:

    Submit your resume and cover letter to careers@csamedical.com

    CSA Medical, Inc. is an equal opportunity employer.

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