Senior Software Engineer - V&V

Key Skills:

Roles and Responsibilities:

• Author, execute, perform, summarize, and report verification and validation test activities of components to a full system device.
• Develop and maintain:
• Test Plans
• Test Procedures
• User and Functional Requirements Testing
• Design Verification
• IQ/OQ/PQ Protocols
• Traceability Matrices
• Final Reports
• Support compliance and closure of regulatory and quality requirements before completing design outputs/program deliverables.
• Apply understanding of Risk Management, FMEA, critical/essential parts identification, system reliability, life/limits testing, and related V&V tasks.
• Participate in the development of V&V methodologies per Quality/Regulatory requirements and industry best practices.
• Lead qualification of lab area, productivity improvement, testing, fixtures, calibration, and data collection.
• Diagnose, isolate, and investigate problem reports; drive product improvements and bug fixes.
• Collaborate with external test houses (e.g., EMI/EMC) to define scope, author test plans, execute, and consolidate reports.
• Ensure Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) in V&V process.
• Participate in continuous improvement by supporting implementation of process and product quality initiatives.
• Possess deep knowledge in test automation tools and developing automation suites.
• Experience with IEC basic safety, EMI-EMC standards.
• Work closely with auditees to understand details and provide objective evidence.
• Adhere to Baxter Quality Management System and support quality audits.
• Support ongoing regulatory inspection readiness via self-assessments, mock inspections, and updated compliance.
• Engage with design & development teams early in the cycle for testability, traceability, and test coverage.
• Conduct pre-verifications/dry runs to refine test plans and procedures.
• Resolve test-related technical issues with design team.
• Present findings/objective evidence with rationale and clear applicability or exclusions.
• Identify/report any quality or compliance concerns and take corrective/preventive action.

Skills Required:

• 5 to 10 years of experience in V&V testing of software, hardware, and systems.
• Relevant technical testing/reliability experience in electro-mechanical, electrical, or software testing.
• Understanding of test methods and verification processes in software, mechanical, electrical, functional, and environmental contexts.
• Experience in writing system, subsystem, and module-level V&V plans, procedures, test execution, and reporting.
• Familiarity with product design methodologies and test practices for both hardware and software.
• Understanding of reliability theory and analysis related to test quantities.
• Experience in medical device or similar domain involving system integration (software & hardware), risk management, and regulatory compliance.
• Deep domain knowledge in medical device design V&V is a plus.
• Adherence to FDA, ISO, IEC design control procedures, regulations, and standards.
• Demonstrated ability to deliver on multiple simultaneous projects.
• Self-motivated with strong interpersonal skills.

Education: