Principal R&D Engineer (Balloon Tech) - Shockwave Medical - Santa Clara California

Company: Disability Solutions
Location: Santa Clara, California
Posted On: 02/06/2025

Johnson & Johnson is recruiting for Principal R&D Engineer for Shockwave Medical Inc. located in Santa Clara, CA.\rAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. \rFor more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.\rAt Johnson & Johnson, we all belong.\rPosition OverviewThe 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. 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.\rEssential Job Functions

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• 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.\r\r More...

      

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