Engineer II – Testing (V&V)

Responsibilities

• Formulate test analysis, test strategies, and automation frameworks for medical product verification and validation.
• Design and develop automation scripts for new product development, sustenance activities, and field issue resolution.
• Implement TDD and BDD methodologies to drive test quality improvements across platforms.
• Identify technical risks at the module and product levels and assist in developing mitigation and recovery plans.
• Drive the application of SDLC principles, including IEC62304, Lean/Agile, CI, and software security.
• Ensure rigorous documentation and adherence to good manufacturing practices within the test process.
• Collaborate with R&D and cross-functional teams to ensure high-quality releases and timely resolution of field issues.

Requirements

• 6-10 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 both manual and automation testing.
• Proficiency with automation tools such as SQUISH, Java, and Python.
• Strong understanding of and adherence to FDA, ISO, and IEC design control procedures, regulations, and standards.
• Experience writing system, subsystem, and module-level verification and validation plans, procedures, and reports.

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.