Principal R&D Engineer (Materials Science and Processing)

Principal R&D Engineer (Materials Science and Processing)

Research & Development Santa Clara, CA

Position Overview

The Principal R&D Engineer (Materials Science and Processing) will use technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. They will be responsible for the advanced research and development of products and processes, resources, and project management activities associated with executing the company's goals and objectives. The catheter development processes include braiding, coiling, and laminating, as well as other catheter prototyping activities. In addition, the Principal R&D Engineer will play the key role in the metrology activities at Shockwave, including materials analysis and failure mode investigations. They will utilize metrology tools including the SEM, Differential Scanning Calorimeter, Dynamic Materials Analyzer, and FTIR Spectrophotometer.

Essential Job Functions

• Provide technical leadership for projects including managing technology development teams.
• Enhance the 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, 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.
• 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 the 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 the 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.

Requirements

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

EEO Employer