R&D Engineer I (Clinical Engineering) - Shockwave Medical

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

Job Function:

R&D Product Development

Job Sub Function:

Biomedical Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a R&D Engineer I – 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 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/.

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.

Position Overview

The R&D Engineer I (Clinical Engineering) will use technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. This person will be working with a multidisciplinary team of Scientists and Engineers to optimize the current platform. This is a hands-on role within the Clinical Engineering team and represents a unique opportunity to operate within a focused pre-clinical studies group to manage studies to support the development of Shockwave Medical’s innovative platform and technology of current and future products.

Essential Job Functions

• Support the design and development of product(s) in full compliance with the company’s Design Control requirements and consistent with FDA, ISO, and MDD requirements.

• Support the prototype and development of proof-of-concept designs, disease models and test methods for evaluation in a simulated environment and support new product designs based on the defined user needs.

• Assist in the analysis, evaluation, sourcing, and coordinate the procurement of new materials to support prototyping and pilot operation.

• Participate on cross-functional development teams that manage projects from concept through commercialization.

• Support procedure room activities for data collection, monitoring and device accountability.

• Support pre-clinical testing and assist in developing pre-clinical research protocols and reports.

• Review and author study protocols for in-vitro and in-vivo studies.

• Maintain preclinical laboratory equipment and supplies, ensuring proper calibration (if necessary) is conducted accordingly.

• Must have excellent organizational skills and be able to record and manage experimental data from various experimental studies ongoing concurrently.

• Support regulatory efforts through understanding of relevant standards and interpretation of FDA Guidance documents.

• May require active participation in research meetings, including making detailed scientific presentations pertaining to study.

• Work cooperatively with a multidisciplinary team of Scientists, Engineers, and Regulatory personnel in other departments.

• Contribute to hands-on in vitro laboratory work as needed, which may include