Staff R&D Engineer

7 days ago

Santa Clara, United States Disability Solutions Full time
Johnson & Johnson is hiring for a Staff R&D Engineer (Advanced R&D)- Shockwave Medical to be located in Santa Clara, CA.

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At 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/.

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For 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.

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At Johnson & Johnson, we all belong.

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Shockwave 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.

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Description

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Position Overview

The Staff R&D Engineer will use technical and leadership skills in the development of innovative products to treat coronary and peripheral vascular disease with potential to expand to other vascular diseases. The Staff R&D Engineer will participate on multiple cross-functional development teams that manage projects from concept through commercialization, with a primary focus on early-stage / phase-zero development. This role will serve as an individual contributor working cohesively with a technical team for the early-stage development period of projects.

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Essential Job Functions
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  • Provide technical leadership for projects in the coronary and peripheral vascular space.
  • Provide Tasks and assignments to technicians as required.
  • Collaborate cross-functionally to gather and define user needs for new products
  • Hands on prototyping to develop proof of concept designs, disease models and test methods based on the defined user needs and requirements.
  • Perform bench testing to ensure appropriate design selection.
  • Work closely with the project Technical leads to formalize test plans.
  • Solve challenging and complex technical problems during the new product development process.
  • 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.
  • Analyze, evaluate, source, and coordinate the procurement of new materials to support prototyping and pilot operation.
  • Develop protocols, test methods, and reports, and perform product assessments on benchtop, in-situ, and in-vivo to prove and de-risk viability and feasibility of new product designs.
  • 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.
  • Participate as SME on product development team(s) that manage projects from concept through transfer to PDP team.
  • Design and develop product(s) in compliance with the company's Design Control requirements and consistent with applicable regulatory requirements.
  • Ensure proper documentation consistent with the company's quality system.
  • Responsible for knowing and planning activities consistent with the company's quality policy and quality objectives.
  • 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.
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