Sr. Quality Product Owner - Shockwave Medical

Role Summary

Senior Quality Product Owner for Shockwave Medical, located in Santa Clara, CA. You will support and optimize quality application systems in manufacturing and product development, acting as the liaison between business stakeholders, IT, and engineering to ensure quality processes support business goals and enable product innovation. This role operates in regulated medical-device environments to uphold standards while enabling 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

• Required: 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).
• Preferred: Bachelor’s degree (Computer Science, Computer / Software Engineering or equivalent)
• Preferred: Experience working in a medical devices regulated industry.
• Required: Knowledge of product development cycles, BOM management, change management, and compliance standards.
• Required: Strong analytical skills with a continuous improvement mindset and attention to detail.
• Required: Excellent communication skills, with the ability to work effectively with cross-functional teams.
• Preferred: Familiarity with Agile or SCRUM project management methodologies.
• Internal pre-identified candidate for consideration; however, all applications will be considered.

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

Additional Requirements

• Internal pre-identified candidate for consideration; however, all applications will be considered.