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San Francisco Bay Area, CA

  • Principal R&D Engineer – Advanced R&D

    Santa Clara, CA

    Position Overview

    The Principal R&D Engineer will use technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. The Principal R&D Engineer will participate on multiple cross-functional development teams that manage projects from concept through commercialization.

    Essential Job Functions

    • Provide technical leadership for projects including managing technology development teams.
    • Responsible for managing technology and other relevant resources.
    • Design and develop product(s) in compliance with the company’s Design Control requirements and consistent with applicable regulatory requirements.
    • Prototype and develop proof of concept designs, disease models and test methods of testing these concepts in a simulated environment and develop new product designs based on the defined user needs.
    • Work with clinical and scientific advisors as well as Key Opinion Leaders in translating clinical needs into design solutions while utilizing these resources to develop and optimize product design.
    • Analyzes, evaluates, sources, and coordinates the procurement of new materials to support prototyping and pilot operation.
    • Participate as SME or core team member on product development team(s) that manage projects from concept through commercialization.
    • 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.
    • Develop protocols/reports and perform product in-vitro, in-vivo as well as verification and validation testing.
    • Perform process-related design tasks to support pilot manufacturing as necessary.
    • Identify suppliers and maintain relationships to ensure the delivery of superior components and services.
    • Enhance the intellectual property position of the company via invention disclosures and patent applications.
    • Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company’s products.
    • Responsible for component and assembly documentation for new products being developed.
    • Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations.
    • Other duties as assigned.


    • Bachelor’s Degree in Mechanical or Biomedical Engineering and 10 years’ experience in engineering OR a Master’s Degree and 8 years’ experience in engineering.
    • Engineering experience in the medical device industry.
    • Experience developing disposable medical devices.
    • Knowledge of disposable peripheral and coronary device design, material selection, and testing.
    • Strong understanding of engineering materials, component selection, and design for reliability and manufacturability.
    • Experience in early stage catheter based cardiovascular devices development is a strong plus.
    • Effective communication skills with all levels of management and organizations.
    • Operate independently and adaptability to changing requirements.
    • Ability to work in a fast-paced environment, managing multiple priorities.
    • Previous experience managing cross functional teams is preferred.
    • Employee may be required to lift objects up to 25lbs.

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