Shockwave Medical Careers

Description

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.

Description    

Position Overview    

The Sr. R&D Mechanical Engineer, Systems will use technical skills in the development of various electro-mechanical design elements for the Shockwave Medical IVL system. The Sr. R&D Mechanical Engineer, Systems will participate in cross-functional development teams to design and release robust mechanical systems and enclosures that are manufacturable, reliable, and serviceable; engage in specification writing and development; execute testing; and provide support to other departments as required.    

Essential Job Functions    

• Mechanical part design utilizing SolidWorks; generating 3D files and 2D drawings (including notes, inspection criteria, and selection of critical dimensions)
• 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
• Develop, source, and evaluate designs based on the defined user needs and specifications 
• Participate on cross-functional development teams that manage projects from concept through commercialization
• 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
• Good written and verbal communication skills, including interfacing with external suppliers
• Provide support to operations and regulatory initiatives as required
• Other duties as needed

Requirements    

• Bachelor’s degree in Mechanical Engineering with 5+  years of product development experience or a master’s degree with 3+ years of product development experience
• Familiarity with various fabrication processes utilized within electro-mechanical assemblies such as 3D printing, machining, injection molding, extrusion, etc.
• Familiarity with risk management processes and applications
• Working knowledge of GDT (Geometric Dimensioning and Tolerancing) and GDP (Good Documentation Practices).
• Engineering experience in the medical device industry
• Experience integrating electrical and mechanical components within assemblies and models.
• Ability to work in a fast-paced environment, managing multiple priorities.
• Experience with JAMA is a plus.
• 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.    

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

EEO Employer