Principal R&D Engineer (Materials Science and Processing)

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.

• Provide technical leadership for projects including managing technology development teams
• Enhance intellectual property position of the company via invention disclosures and patent applications.
• Support a long-term strategy with the Materials Science and Processing Team for examining new designs, advanced materials and processing methods for next-generation catheter concepts.
• Design and develop product(s) in compliance with the company's Design Control requirements and consistent with applicable regulatory requirements.
• New product testing, including comparison testing with competitor products, bench testing, animals testing and clinical evaluation, and 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.
• 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 regulations.
• Other duties as assigned.

• BS in Mechanical, Biomedical Engineering, Materials Science or Physics and 10 years' engineering experience in Materials Science related work OR a MS and 8 years' engineering experience in Materials Science related work.
• Experience developing disposable medical devices is highly desirable.
• Proficiency utilizing metrology tools including SEM, DSC, DMA and FTIR spectrophotometer as well as writing reports to evaluate the data.
• Strong understanding of engineering materials, component selection, and design for reliability and manufacturability.
• Experience in early-stage catheter-based device processing including braiding, coiling and laminating is a strong plus.
• Effective communication skills with all levels of management and organizations.
• Operate independently and adaptability to changing requirements.
• Ability to work in a fast-paced environment, managing multiple priorities.
• May be required to lift objects up to 25lbs

Market Range:

$144,000 - $180,000
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: Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards

EEO Employer