Senior R&D Engineer, Systems

3 days ago

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

Shockwave Medical is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our mission is 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 Senior R&D Engineer, Systems will work with cross-functional teams to develop and sustain products at Shockwave Medical that satisfy customer needs and drive business strategies. This role will engage in specification writing and development, test and report writing and development, execute testing, DHF maintenance, and provide support to other departments as required.

Key Responsibilities:
  • Design and develop product(s) and documentation in full compliance with the company's Design Control requirements and consistent with FDA, ISO, and MDD criteria.
  • Participate on cross-functional development teams that manage projects from concept through commercialization.
  • Evaluate existing document architecture and assess for gaps and dependencies.
  • Work with stakeholders to establish project needs and functional group interfaces.
  • Work with on-market groups and data sets to assess device performance.
  • Support sustaining activities for on-market products.
  • Support quality audits and follow-up activities.
  • Ensure lab notebooks are documented in a timely manner and consistent with the applicable SOP.
  • Develop protocols/reports and perform product in-vitro, in-vivo verification and validation testing.
Requirements:
  • Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or Electrical Engineering with 5+ years of medical device experience, or a Master's degree in Biomedical Engineering, Mechanical Engineering, or Electrical Engineering with 3+ years of medical device experience.
  • Familiarity with Design History Files (DHF), Design Master Records (DMR), Traceability Matrices, and other outputs of the Product Development Process.
  • Familiarity with risk management processes and applications including FMEA, FTA and general risk analysis.
  • Strong working knowledge of and the medical device development process.
  • Working knowledge of GDP (Good Documentation Practices) and an ISO 13485 regulated environment.
  • Experience with JAMA is a plus.
  • 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.

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