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Senior R&D Engineer

1 month ago

Santa Clara, California, United States Shockwave Medical Full time
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 Senior R&D Engineer to join our team and contribute to the development of innovative products to treat ophthalmic diseases.

The successful candidate will be responsible for advanced research and development of products and processes, resources, and project management activities associated with executing the company's goals and objectives.

Key Responsibilities
  • Enhance intellectual property position of the company via invention disclosures and patent applications.
  • Support a long-term strategy with Technologies Development Team for examining new designs, advanced materials and processing methods for next-generation ophthalmology device concepts.
  • Design and develop product(s) in compliance with the company's Design Control requirements and consistent with applicable regulatory 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.
  • New product testing, including comparison testing with competitor products, bench testing, animals testing and clinical evaluation, and including protocol and test report with clinical and scientific advisors as well as Key Opinion Leaders in translating clinical needs into design solutions while utilizing these resources to develop and optimize product design.
  • Participate as SME or core team member on product development team(s) that manage projects from concept through the technology development phase.
  • Responsible for ensuring proper documentation consistent with company's quality system.
  • Develop protocols/reports and perform product in-vitro, in-vivo as well as verification and validation testing.
  • 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.
  • Provide regular updates of key milestones and issues to the project team as well as management.
  • Support company goals and objectives, policies and procedures, Quality Systems, and FDA duties as assigned.
Requirements
  • BS in Mechanical or Biomedical Engineering and 10 years' engineering experience in medical device development OR a MS and 8 years' engineering experience in medical device development.
  • Experience developing disposable medical devices.
  • 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 independently and adaptability to changing requirements.
  • Ability to work in a fast-paced environment, managing multiple priorities.
  • Employee may be required to lift objects up to 25lbs.
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
  • Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards