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.
The Principal R&D Engineer will use technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. The Principal R&D Engineer will participate on multiple cross-functional development teams that manage projects from concept through commercialization.
Essential Job Functions
- Provide technical leadership for projects including managing technology development teams
- Responsible for managing technology and other relevant resources.
- Design and develop product(s) in compliance with the company’s Design Control requirements and consistent with applicable regulatory 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.
- 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.
- Analyzes, evaluates, sources, and coordinates the procurement of new materials to support prototyping and pilot operation.
- Participate as SME or core team member on product development team(s) that manage projects from concept through commercialization.
- Responsible for ensuring proper documentation consistent with company’s quality system.
- Responsible for knowing and planning activities consistent the company’s quality policy and quality objectives.
- 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 as necessary.
- Identify suppliers and maintain relationships to ensure the delivery of superior components and services.
- Enhance the intellectual property position of the company via invention disclosures and patent applications.
- 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.
- Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations.
- Other duties as assigned. These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel.
- Bachelor’s Degree (Master’s or PhD preferred) in Mechanical, Biomedical Engineering, or equivalent experience.
- Minimum of 10 years’ experience in engineering preferably in the medical device industry.
- Experience developing disposable medical devices.
- Knowledge of disposable peripheral and coronary device design, material selection, and testing.
- Strong understanding of engineering materials, component selection, and design for reliability and manufacturability.
- Experience in early stage catheter based cardiovascular devices development 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.
- Previous experience managing cross functional teams is preferred.
- Employee may be required to lift objects up to 25lbs.
Shockwave Medical offers a competitive total compensation package including comprehensive benefits (medical, dental, vision) as well as pet insurance and student loan refinancing support.