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Staff R&D Engineer (Model & Claims Development) - Shockwave Medical

Company: Disability Solutions
Location: Santa Clara
Posted on: February 15, 2025

Job Description:

Johnson & Johnson is hiring for a Staff R&D Test Engineer - Shockwave Medical to join our team 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.\rShockwave Medical, Inc., recently acquired by Johnson & Johnson, 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.\rPosition OverviewThe Staff R&D Engineer (Model and Claims Development) will use technical skills in the evaluation and testing of innovative products as well as the development of clinically relevant models for peripheral, coronary, and heart valve diseases. The Staff R&D Engineer will work closely with marketing and regulatory to design bench tests, model designs, and test plans drive the development of marketing claims to support business requirements. He or she will work closely with marketing to interface with customers to ensure the tests and models meet physician requirements. This Staff R&D Engineer will be expected to become the resident expert on competitive and complementary technology.\rEssential Job Functions

  • \r
  • Evaluate and test Shockwave devices to support development of marketing claims
  • Test on market or soon to be launched products
  • Develop or improve disease models and test methods of testing these concepts in a simulated environment
  • Support a long-term strategy with Technologies Development Team for evaluating new models and test methods for next-generation catheter concepts
  • Participate in cross-functional development team that develops products from Phase II through the full market launch
  • 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
  • Responsible for ensuring the lab notebooks are documented in a timely manner and consistent with the applicable SOP
  • Support the development of protocols/reports and product testing in in-vitro and pre-clinical models, as necessary for claims development
  • 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

Keywords: Disability Solutions, Santa Clara , Staff R&D Engineer (Model & Claims Development) - Shockwave Medical, Healthcare , Santa Clara, California

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