Senior R&D Engineer

17 hours ago

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

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

Job Summary

The Sr. R&D Engineer will utilize technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. This role will participate on multiple cross-functional development teams that manage projects from concept through commercialization.

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 teams that manage projects from concept through commercialization.
  • Responsible for ensuring proper documentation consistent with the company's quality system.
  • Responsible for knowing and planning activities consistent with the company's quality policy and quality objectives.
  • New product testing, including comparison testing with competitor products, bench testing, animal testing, and clinical evaluation, including protocol and test report documentation.
  • 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.
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.
  • Proficiency in SOLIDWORKS and Design of Experiments is a strong plus.
  • Knowledge of catheter assembly and manufacturing processes 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:

  • 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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