Sr. Quality Product Owner - 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 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

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Job Function:

Technology Product & Platform Management

Job Sub Function:

Business Systems Analysis

Job Category:

Scientific/Technology

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Sr. Quality Product Owner – Shockwave Medical to join our team located in Santa Clara, CA.

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. Quality Product Owner in the manufacturing and product development industry plays a key role in supporting and optimizing quality application systems. This individual acts as the liaison between business stakeholders, IT teams, and engineering departments to ensure that quality processes support business goals, improve efficiency, and enable product innovation. The Quality Business Analyst will work in regulated environments such as medical devices, where adherence to standards is critical.

Essential Job Functions

• Business Process Analysis & Documentation: Work with stakeholders to understand business processes, gather requirements, and develop detailed functional specifications and workflows.

• Quality System Support: Serve as the primary point of contact for troubleshooting quality issues and enhancements, ensuring system performance and data integrity across the organization.

• User Support & Training: Provide training to end-users, develop standard operating procedures (SOPs), and create process flow documentation to improve Quality systems utilization.

• System Enhancements & Optimization: Collaborate with the IT and engineering teams to implement new features, system updates, and customization that align with business goals.

• Cross-Functional Collaboration: Work closely with Manufacturing, and Quality teams to improve Quality applications workflows, ensure regulatory compliance, and enhance collaboration throughout the product lifecycle.

• Data Management & Reporting: Monitor Quality system data for accuracy and completeness, generate reports, and track key performance indicators (KPIs) to provide actionable insights to management.

• Change Management: Manage change requests and control updates to the quality system, ensuring proper validation and documentation of changes.

Requirements

• Bachelor’s degree preferred (Computer Science, Computer / Software Engineering or equivalent)

• 5+ years of relevant experience with 2+ years of experience as a quality business analyst working in an MFG IT environment and 2+ years of experience in a Business Analyst or similar role, with hands-on experience in Quality systems (e.g., Windchill, Teamcenter, Enovia).

• Knowledge of product development cycles, BOM management, change management, and compliance standards.

• Experience working in a medical devices regulated industry is preferred.