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San Francisco Bay Area, CA

  • Senior R&D Mechanical Engineer

    The Senior / Principal Mechanical Engineer will be responsible for design and development of mechanical and electromechanical medical devices.

    Responsibilities:

    • Applies engineering knowledge and skills as technical engineer for all phases of development projects.
    • Participates in and often leads efforts to create product specifications and develop novel designs to meet those specifications.
    • Participates in hands-on development, fabrication and testing of device prototypes.
    • Generates and executes test protocols to verify functionality and generates test reports.
    • Generates and maintains appropriate design and manufacturing process documentation for Design History File (DHF).
    • Often coordinates and manages other technical staff to work on specific tasks.
    • Communicates directly with clients to understand project needs and present results.
    • Effectively interfaces with and manages suppliers to fabricate prototypes and components.
    • Participates in risk management activities, and develops and implements risk mitigation strategies.

    Requirements:

    • Minimum BSE/BSME with 10-20 years of experience within the Medical Device industry.
    • Extensive experience with design and development of mechanical and electro-mechanical devices, preferably class III devices.
    • Significant experience as a technical team leader.
    • Experience with project management preferred.
    • Must be proficient with Solidworks.
    • Experience in creating and managing product requirements, writing verification test protocols and test reports, and generating manufacturing procedures.
    • Experience with design for manufacturing and assembly.
    • Excellent communication skills, both written and oral.
    • Deep knowledge of medical device design control processes.


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