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 will use technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. The Sr. R&D Engineer will be responsible for advanced research and development of products and processes associated with executing the company’s goals and objectives.
Essential Job Functions
- 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
- Enhance intellectual property position of the company via invention disclosures and patent applications
- Analyzes, evaluates, sources, and coordinates the procurement of new materials to support prototyping and pilot operation
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New product testing, including comparison testing with competitor products, bench testing, animal testing and clinical evaluation, including protocol and test report documentation
- Work 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
- Partner with PDP teams to translate finished device requirements
- 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
- 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
- May provide updates of key milestones and issues to the project team as well as management
- Responsible for ensuring proper documentation consistent with company’s quality system
- Other duties as assigned
Requirements
- Bachelor’s degree in Engineering (preferably Mechanical, Materials Science, Chemical or Biomedical/Bioengineering) with a minimum of 5 years’ experience in medical device engineering or a master’s degree in Engineering and 3+ years’ experience in medical device engineering
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Must have extensive previous experience designing and prototyping catheters
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Knowledge of catheter device design, material selection, and testing
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Strong understanding of engineering materials, component selection, and design for reliability and manufacturability
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Experience in early-stage catheter based cardiovascular devices development is a strong plus
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Effective communication skills with all levels of management and organizations
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Ability to work in a fast-paced environment, managing multiple priorities
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Ability to operate as a team and/or independently while demonstrating flexibility to changing requirements
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Proficiency in SOLIDWORKS and Design of Experiments is a strong plus
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Employee may be required to lift objects up to 25lbs
Market Range: $120,300 - $134,090
Exact compensation may vary based on skills, expertise, 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
