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San Francisco Bay Area, CA

  • R&D Design Engineer (II or Senior)

    San Jose, CA

    Position Summary: Perform design and development projects for medical devices in support of company’s strategic plan.  Responsible for initiation and completion of development projects on time and with-in budget.  

    Authorities:

    • Has authority to control design and release of product to production to ensure optimum quality, complete documentation, and verified performance.

    Duties and Responsibilities:

    • Design and develop product(s) in full compliance with the company’s Design Control requirements and consistent with FDA QSR, ISO, MDD, CE Mark, and Canadian Medical Devices Regulations.
    • Responsible for ensuring proper documentation consistent with company’s quality system.
    • Responsible for knowing and planning activities consistent the company’s quality policy and quality objectives.
    • Responsible for ensuring the lab notebooks are documented in a timely manner and consistent with the applicable SOP.
    • Apply engineering knowledge and managerial skills to the design and develop new products as well as product changes and enhancements which are consistent with a zero defect level as well as low product cost.
    • Responsible for Good Manufacturing Practices, international compliance standards, and company procedures.
    • New product testing, including comparison testing with competitor products, bench testing, animals testing and human testing, and including protocol and test report documentation.
    • Responsible for overall verification efforts.
    • Responsible for all project documentation.
    • Participate in Design Reviews.
    • Responsible for compliance with QSR Design Control.
    • Support sales and marketing, clinical and regulatory efforts.  

    Position Requirements: 

    • Word, Excel, Project, SolidWorks and PowerPoint or equivalent required.    
    • Ability to work independently, investigate, troubleshoot and resolve issues. 
    • Experience with ISO/CE certification desired. 
    • Working knowledge of current FDA Quality Systems Regulation, emphasizing Design Control.
    • Excellent communications, personnel management, and time management skills required.
    • Extensive knowledge of company products and business strategy required.

    Education Requirements:

    • BS Engineering Degree

    Experience Requirements:

    • Minimum 3+ years prior experience in medical product development or 5 years other product development experience.

     


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