R&D Engineer II

7 days ago

Minneapolis, Minnesota, United States Shockwave Medical Full time
Job Title: R&D Engineer II

Shockwave Medical is a leading medical device company dedicated to revolutionizing the treatment of advanced cardiovascular disease. We are seeking a highly skilled R&D Engineer II to join our team in Minnesota.

Job Summary

The R&D Engineer II will play a critical role in the development of innovative products to treat peripheral, coronary, and heart valve diseases. This position will focus on process development for the engineering team, providing oversight to pilot manufacturing/testing, and ensuring products transition from development into full production.

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

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

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