Sr. R&D Engineer, Systems

at  Shockwave Medical

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

POSITION OVERVIEW

The Sr. 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. The Sr. R&D Engineer, Systems 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.

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 820.30 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.
  Market Range:
  $113,000 - $141,000
  Exact compensation may vary based on skills, experience, and location.

Please refer the Job description for details