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Shockwave Medical Sr. R&D Engineer (Clinical Engineering) in Santa Clara, California

Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Sr. R&D Engineer will use technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. 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

  • Analyze, evaluate, source, and coordinate the procurement of new materials to support prototyping and pilot operation

  • Participate on a cross-functional development team that manage projects from concept to commercialization

  • Responsible for ensuring proper documentation consistent with company’s quality system

  • Responsible for knowing and planning activities consistent with the company’s quality policy and quality objectives

  • Responsible for ensuring that 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 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 in Mechanical or Biomedical Engineering with 5 years’ experience in engineering or a master’s degree with 3 years’ experience in engineering

  • Engineering experience in the medical device industry is highly preferred

  • Knowledge of disposable peripheral and coronary device design, material selection, and testing

  • Strong foundation in basic science including engineering principles, anatomy, and physiology

  • 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

  • Ability to work in a fast-paced environment, managing multiple priorities

  • Operate as a team and/or independently while demonstrating flexibility to changing requirements

  • Employee may be required to lift objects up to 25lbs

Benefits

Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks -

Core Benefits: Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance

Perks: ESPP, Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards

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