Principal R&D Engineer; Balloon Tech - Shockwave

Principal R&D Engineer (Balloon Technology) – Shockwave Medical

Johnson & Johnson is hiring for a Principal R&D Engineer (Balloon Technology) – 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.

Position Overview

The Principal R&D Engineer (Balloon Technology) 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. They will support product development efforts in our IVL balloon related devices as well as develop new balloon technologies to address the anticipated needs of future applications.

Essential Job Functions

• Provide technical leadership for projects including managing technology development teams
• Design and develop product(s) in compliance with the company's Design Control requirements and consistent with applicable regulatory requirements.
• Partner with the Adv. R&D and PDP teams to translate finished device requirements to the balloon component level
• Survey emerging technologies in the balloons and polymer science space and explore novel applications to support company strategic goals
• Identify practical ways to apply new balloon/polymer technologies to improve current and next generation products
• Execute a long-term strategy with Technologies Development Team for examining new designs, materials as well as processing methods for next-generation balloon concepts
• 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 as well as to maintain relationships with suppliers to ensure the delivery of superior components and services.
• Participate as SME or core team member on product development team(s) that manage projects from concept through commercialization.
• Responsible for ensuring proper documentation (e.g., component and assembly drawings) 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.
• 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.
• Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations.
• Other duties as assigned.

Qualifications

• Bachelor's Degree in Mechanical Polymer Science or other relevant engineering/technical degree and 10 years' experience in the medical device industry or a Master's Degree and 8 years' experience in medical devices.
• 3+ years of experience in polymer product development including experience with balloon blow molding.
• 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.
• Proven track record in technology…