Quality Engineer II - Shockwave Reducer

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:
Supply Chain Engineering

Job Sub Function:
Quality Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
New Brighton, Minnesota, United States of America

Job Description:

Johnson & Johnson is hiring for a Quality Engineer II to join our Shockwave Reducer team located in New Brighton, MN.

Shockwave Medical is a fast-growing medical device company focused on revolutionizing the treatment of advanced cardiovascular disease.

With the innovative Shockwave Reducer System, we are creating new opportunities for patients and physicians in the treatment of refractory angina – long-lasting, debilitating chest pain that cannot be controlled by traditional medicine or surgical procedures and affects millions of people world-wide.

To support the growing Shockwave Reducer business, we are establishing a facility in New Brighton, MN (SWMI-MN) focused on the Reducer.

We are actively seeking motivated individuals who bring relevant industry experience and are enthusiastic about learning and growing within the Reducer business.

Position Overview:
The Quality Engineer II (QE II) will have direct responsibilities related to the establishment and qualification of the SWMI-MN facility.

This includes development, implementation, and maintenance of SWMI-MN procedures and processes.

In addition, the QE II supports development, manufacturing, and post-production activities and works cross-functionally to resolve technical problems.

This QE II participates in strategic decisions regarding project scope, risk management, design updates, process optimization, and material disposition.

Responsibilities may include test method development/validation, root cause/failure analysis, and post-market surveillance including complaint investigations and complaint monitoring/trending.

The ideal candidate will offer innovative solutions and support the successful execution of quality engineering activities across the facility and product lifecycle.

Essential Job Functions:


* Develop, apply, and maintain robust quality standards for materials, components, and products, ensuring full alignment with regulatory and company requirements.


* Design and implement advanced methods and procedures for inspection, testing, and evaluation to assess the precision and accuracy of products, sub-assemblies, and production equipment.


* Prepare comprehensive documentation, including inspection/testing procedures,...