Principal R&D Engineer - Shockwave Medical

Principal R&D Engineer – Shockwave Medical

Johnson & Johnson is hiring for a Principal R&D Engineer – Shockwave Medical to join our team located in Santa Clara, CA.

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio 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.

• 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.

• Bachelor's Degree in Mechanical or Biomedical Engineering and 10 years' experience in engineering OR a Master's Degree and 8 years' experience in engineering.
• Engineering experience 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.
• Strong hands-on experience with CAD software like Solidworks.
• 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.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via careers or contact AskGS to be directed to your accommodation resource.