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Principle R&D Engineer

Company: Lawinger Consulting Inc.
Location: Santa Clara
Posted on: November 18, 2021

Job Description:

Principle R&D Engineer Santa Clara, CA 95054Fulltime - Direct Hire. Position OverviewThe Principle R&D Engineer will use technical skills in the development of innovative cardiovascular catheter products. The Staff 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. These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel.. Requirements--- 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.

Keywords: Lawinger Consulting Inc., Santa Clara , Principle R&D Engineer, Engineering , Santa Clara, California

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