R&D Engineer II

4 weeks ago

Santa Clara, California, United States Shockwave Medical Full time

Job Title: R&D Engineer II

Job Summary:

Shockwave Medical is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. We are seeking a highly skilled R&D Engineer II to join our team and contribute to the development of innovative products to treat peripheral, coronary, and heart valve diseases.

Key Responsibilities:

  • Support the development of product(s) for manufacturing in full compliance with the company's Design Control requirements and consistent with FDA, ISO, and MDR requirements.
  • Work on prototype and develop designs, processes, and test methods in support of new product designs scaling for commercialization.
  • Represent R&D on manufacturing-related project activities, including internal and external requests.
  • 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.
  • Write protocols/reports and perform product 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.
  • 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 2+ years' experience in engineering or a master's degree in Mechanical or Biomedical Engineering with 1 year of engineering experience preferred.
  • Engineering experience in the medical device industry is highly preferred.
  • Knowledge of disposable peripheral and coronary device design, material selection, and testing preferred.
  • 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 while managing multiple priorities.
  • Operate as a team and/or independently while demonstrating flexibility to changing requirements.

Benefits:

  • Competitive total compensation package.
  • 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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