Sr. Quality Product Owner - Shockwave Medical

Role Summary

The Sr. Quality Product Owner – Shockwave Medical, based in Santa Clara, CA, is responsible for supporting and optimizing quality application systems within a regulated medical-device environment. The role serves as the liaison between business stakeholders, IT teams, and engineering to ensure that quality processes support business goals, improve efficiency, and enable product innovation. This position supports the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease.

Responsibilities

• 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.

Qualifications

• 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.
• Strong analytical skills with a continuous improvement mindset and attention to detail.
• Excellent communication skills, with the ability to work effectively with cross-functional teams.
• Familiarity with Agile or SCRUM project management methodologies is desirable.

Skills

• Analytical Reasoning
• Business Requirements Analysis
• Coaching
• Critical Thinking
• Human-Computer Interaction (HCI)
• Network Configuration Management
• Operating Systems (OS)
• Project Management
• Scripting Languages
• Software Development Management
• Systems Analysis
• Systems Development
• Systems Management
• Technical Credibility
• Technologically Savvy

Education

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