Senior Engineer, V&V

Responsibilities

• Formulate test analysis, test strategies, and automation frameworks for medical product portfolios.
• Take complete ownership of product or release testing, 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 early in the design cycle (Sprints) to ensure test coverage.
• Lead investigations into root causes for quality issues and drive corrective/preventive actions.
• Mentor peers and engineers in specialized technical expertise and testing processes.

Requirements

• 8-12 years of experience in Test/V&V activities 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 tools such as SQUISH, Java, and Python.
• Proven experience delivering medical devices in compliance with IEC, FDA, and ISO standards.
• Experience writing system, subsystem, and module-level verification and validation plans and reports.
• Strong understanding of design control procedures and regulatory requirements.

Preferred Qualifications

• Experience technically leading a team of test engineers.
• Familiarity with reliability theory and analysis.
• Experience working in a global, multi-site environment.

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.