Sr. R&D Engineer; Clinical Engineering - 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.

Learn more at

Job Function:

R&D Product Development

Job Sub Function:

Biomedical Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Milpitas, California, United States of America, Mountain View, California, United States of America, Palo Alto, California, United States, San Francisco, California, United States of America, San Jose, California, United States of America, Santa Clara, California, United States of America, South San Francisco, California, United States of America

Job Description:

Johnson & Johnson is hiring for a
** Sr R &D Engineer (Clinical Engineering) – Shockwave Medical
** to join our team located in Santa Clara, CA
.

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.

Learn more at

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 Sr. R&D Engineer (Clinical Engineering) will use technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. The Sr. R&D Engineer will participate in multiple cross-functional development teams that manage projects from concept through commercialization.

• Design and develop product(s) in full compliance with the company’s Design Control requirements and consistent with FDA, ISO, and MDD requirements
• 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
• Analyze, evaluate, source, and coordinate the procurement of new materials to support prototyping and pilot operation
• Participate in cross-functional development team that manage projects from concept through commercialization
• Responsible for ensuring proper documentation consistent with company’s quality system
• Responsible for knowing and planning activities consistent with the company’s quality policy and quality objectives
• Responsible for ensuring that lab notebooks are documented in a timely manner and consistent with the applicable SOP
• Develop protocols/reports and perform product in-vitro, in-vivo as well as verification and validation testing
• Perform process-related design tasks to support pilot manufacturing
• Identify suppliers and maintain relationships to ensure the delivery of superior components and services
• 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

• Bachelor’s degree in Mechanical…