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Sr. R&D Engineer - Cardiovascular Catheter Experience

Position Overview
The Sr. R&D Engineer will use technical skills in the development of innovative cardiovascular catheter products. The Sr. R&D Engineer 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 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 cross-functional development team 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
•    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
 
Requirements
•    Bachelor’s Degree (Master’s preferred) in Mechanical or Biomedical Engineering
•    Minimum of 5 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 resume in confidence for immediate consideration.

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