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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 Principal Quality Engineer (Design Assurance) to support the Shockwave Reducer business 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 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 Principal Quality Engineer (Design Assurance) is responsible for ensuring medical devices are designed, developed, and transferred to manufacturing in compliance with applicable quality system and regulatory requirements. This role partners closely with R&D, Manufacturing, Regulatory Affairs, Clinical Affairs, and Marketing to provide hands-on Design Assurance support throughout new product development. This role applies and interprets relevant medical device standards and regulations as they relate to design and development activities, advising design teams on the quality and compliance impacts of design decisions. Operating with a high degree of autonomy, the Principal Quality Engineer is expected to influence design assurance strategy across programs, provide mentoring and technical guidance to senior engineers, and serve as a subject matter expert during regulatory interactions. This role provides practical, execution‑focused quality engineering support with an emphasis on risk management, verification and validation oversight, and design transfer, enabling timely and compliant product launches.

Essential Job Functions

Lead quality assurance for new product development:

• Partner with design teams to ensure compliance with ISO 13485 and applicable regulatory requirements

• Serve as technical subject matter expert on regulatory standards, statistical methods, test design, and acceptance criteria

• Participate in design reviews to provide an independent perspective on compliance and risk

• Ensure Design History Files (DHFs) are complete, accurate, and inspection-ready throughout the development lifecycle

• Develop and maintain Risk Management Files including plans/reports, hazard analyses, FMEAs, risk control strategies, and risk assessments

• Support development and execution of incoming inspection plans, first article inspections (FAI), and related documentation to ensure alignment with design intent

• Advise design teams on quality system and regulatory implications of design decisions and changes

• Provide Design Assurance oversight for Verification and Validation (V&V) activities

  • Review and approve protocols, test methods, and reports

  • Provide quality oversight to ensure test strategies, a