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R&D Engineer

Company: Lawinger Consulting Inc.
Location: Santa Clara
Posted on: November 19, 2021

Job Description:

R&D Engineer--
Santa Clara, CA--
Fulltime - Direct Hire Position Overview
The R&D Engineer II will use technical skills in the development of innovative cardiovascular catheter products. The R&D Engineer II will participate on multiple cross-functional development teams that manage projects from concept through commercialization. Essential Job Functions
--- Design and develop product(s) in full compliance with the company's Design Control requirements and consistent with FDA, ISO, and MDD requirements
--- Prototype and develop a 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
--- Analyzes, evaluates, sources, and coordinates the procurement of new materials to support prototyping and pilot operation
--- Participate on the cross-functional development team that manage projects from concept through commercialization
--- Responsible for ensuring proper documentation consistent with the company's quality system
--- Responsible for knowing and planning activities consistent with 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
--- 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
--- Identify suppliers and maintain relationships to ensure the delivery of superior components and services
--- Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to the 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
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Requirements
--- Bachelor's Degree (Master's preferred) in Mechanical or Biomedical Engineering
--- Minimum of 3 years experience in engineering in the medical device industry
--- Knowledge of disposable peripheral catheter 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 This is a permanent FULL-TIME hire position in Santa Clara, CA, and requires the position to be located onsite. No visa sponsorship is available for this opportunity but relocation is possible for exceptionally well-qualified candidates. Please send your resume in confidence for immediate consideration.
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Keywords: Lawinger Consulting Inc., Santa Clara , R&D Engineer, Engineering , Santa Clara, California

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