Principal R&D Engineer; Sustaining - Shockwave

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 Med Tech, 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.

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Job Function:

R&D Product Development

Job Sub Function:

R&D Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Principal R&D Engineer (Sustaining) – Shockwave 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 and leadership skills in the development and sustaining of innovative products to treat arterial disease. The Principal R&D Engineer will participate on multiple cross‑functional teams that manage projects in support of base business and development.

• Provide technical leadership for projects in coronary and peripheral artery space.
• Provide mentorship to other engineers and assignments to technicians as required.
• Develop and maintain technical documentation such as drawings for equipment, fixtures, components, and assemblies for manufacturing processes.
• Supports pilot manufacturing as well as commercial production
• Support commercial products as subject matter expert on product design, including design changes and regulatory inquiries.
• Prototype and develop proof of concept designs and test methods based on the defined user needs and requirements.
• Represent R&D in cross‑functional teams that drive geographical expansion of products.
• Solve challenging and complex technical problems during the new product development process and in support of commercial products.
• Analyze, evaluate, source, and coordinate the procurement of new materials to support prototyping and pilot operation.
• Develop protocols/reports and perform product assessment as well as verification and validation testing.
• Perform process‑related design tasks to support pilot manufacturing, utilizing Design for Manufacturing principles and working with assemblers to ensure robust processes.
• 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 or core team member on product development team(s) that manage projects from concept through commercialization.
• 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 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.
• 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.
• Experience in early‑stage catheter and/or lead based cardiovascular device…