Senior Engineer, V&V

Responsibilities

• Formulate test analysis, test strategies, and automation frameworks for medical product verification and validation.
• Take complete ownership of testing for products or releases, ensuring high-quality deliverables through both manual and automation testing.
• Develop automation scripts and design choices for new product development and sustenance activities.
• Implement TDD and BDD methodologies to ensure requirements testability and design traceability.
• Create Installation, Operational, and Performance Qualification protocols, traceability matrices, and final reports.
• Partner with R&D and design teams during early design cycles (Sprints) to ensure test coverage.
• Lead investigations into root causes for quality or compliance concerns and drive corrective actions.
• Mentor peer engineers and lead the qualification of lab areas to improve productivity.

Requirements

• 8-12 years of experience in Test/V&V activities specifically for medical products.
• Bachelor's Degree in Software Engineering, Computer Science, Bio-Medical, or a related field.
• Deep hands-on expertise in manual and automation testing using SQUISH, Java, and Python.
• Proven experience delivering medical devices in compliance with IEC, FDA, and ISO standards.
• Strong experience in writing system, subsystem, and module-level V&V plans and procedures.
• Experience technically leading a team of test engineers.

Preferred Qualifications

• Familiarity with reliability theory and analysis.
• Experience working in a global, multi-site environment.
• Strong systems mindset and advanced problem-solving abilities.

About the Company

Baxter is a global healthcare leader dedicated to a mission to save and sustain lives. We redefine healthcare delivery through scientific innovation, focusing on connected monitoring, respiratory health, cardiology, and intelligent diagnostics to meet the needs of patients worldwide.