Sr. R&D Engineer

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:

New Brighton, Minnesota, United States of America

Job Description:

Johnson & Johnson is hiring for a Sr R&D Engineer – Shockwave Medical to join our team located in New Brighton, MN.

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 Sr. R&D Engineer will use technical skills in the development of innovative products to treat treat coronary artery disease and angina. The Sr. R&D Engineer will participate on multiple cross-functional development teams that manage projects from concept through commercialization.

Essential Job Functions

• 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
• Analyzes, evaluates, sources, and coordinates the procurement of new materials to support prototyping and pilot operation
• Participate on 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 the company’s quality policy and quality objectives
• Responsible for ensuring the 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

Requirements

• Bachelor’s degree in Mechanical or Biomedical Engineering with 5 years’ experience in engineering or a master’s degree with 3 years’ experience in engineering
• Engineering experience in developing catheters, access delivery systems, and/or implantable devices
• Experience in catheter and/or implantable device testing and test method development
• Experience in developing bench anatomical models for device testing  
• Exp