R&D Engineer; Process Development - Shockwave Medical

Position: Staff R&D Engineer (Process Development) - 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 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:

R&D Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

New Brighton, Minnesota, United States of America

Job Description:

Johnson & Johnson is hiring for a Staff R&D Engineer (Process Development) - Shockwave Medical to join our team located in New Brighton, Minnesota.

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.

Position Overview

The Staff R&D Engineer (Process Development) will leverage advanced technical expertise to design and optimize innovative products for treating cardiovascular diseases. As the process development subject matter expert, this role will lead early prototype creation, oversee pilot manufacturing and testing, and guide product transition from development to full-scale production. Partnering closely with R&D, operations, regulatory, and quality teams, the engineer will drive process development, validation, and implementation across multiple cross-functional projects.

Essential Job Functions

* Design and develop product(s) for manufacturing in compliance with the company's Design Control requirements and applicable regulatory requirements.

* Prototype and develop proof of concept process designs and bench models to test these concepts in a simulated environment.

* Develop, validate, and maintain test methods.

* Develop new catheter manufacturing processes based on design intent and DFM principles.

* Develop and maintain technical documentation such as drawings for equipment, fixtures, components, and assemblies for manufacturing processes.

* Performs testing, analyze results and provides recommendations for design selection.

* Analyzes, evaluates, sources, and coordinates the procurement of new materials to support prototyping pilot operation and design verification and validation activities.

* Develop protocols/reports and perform product in-vitro, in-vivo as well as verification and validation testing.

* Participates in technical design reviews to ensure all design inputs and user needs are met.

* Supports product development teams in executing projects from concept to commercialization.

* Supports base business and/or continuous improvement projects.

* Support commercial products as subject matter expert on product design, including design changes and regulatory inquiries.

* 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.

* Supports pilot manufacturing as well as commercial production.

* Identify and maintain relationships…