Senior R&D Engineer

3 days ago

Santa Clara, California, United States Shockwave Medical Full time
Job Title: Sr. R&D Engineer

Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease.

Job Overview

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

Key Responsibilities
  • 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 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 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
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 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
Benefits

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

  • 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
  • Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards

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