Principal Quality Engineer, Design Assurance – 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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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, acceptance criteria, and sample sizes are appropriate and compliant with applicable standards Serve as a quality advisor for V&V activities including biocompatibility, sterilization validation, packaging validation, and shelf‑life studies Lead or support test method validation (TMV) activities to ensure methods are suitable for their intended use and comply with internal and regulatory expectations Perform or witness hands-on Design V&V testing when needed to support design assurance assessments Partner with to Manufacturing and Operations on design transfer and validation Support equipment and process validation activities (IQ/OQ/PQ) associated with new product introduction Ensure manufacturing processes, controls, and validations support design intent and regulatory requirements Support Contract Manufacturing and Supplier Quality in identifyi