Software Test Method Validation (TMV)

Summary:

Results-driven Software \& Systems Verification Engineer with 5\+ years of experience in FDA-regulated medical devices, embedded systems, and molecular diagnostics. Expertise in Software Verification \& Validation (V\&V), automated testing, embedded firmware validation, and risk-based testing aligned with IEC 62304, ISO 13485, ISO 14971, IEC 62366, IEC 60601/61010, and FDA 21 CFR Part 11/820 regulations. Proven success in validating infusion pumps, hemodialysis systems, and PCR-based diagnostic platforms while supporting FDA 510(k) submissions, CAPA, and audit readiness.

Key Responsibilities:

• Develop, execute, and maintain software/system verification protocols and test strategies for FDA-regulated medical devices.
• Perform functional, integration, regression, and system-level testing for embedded software and firmware applications.
• Validate safety-critical workflows including alarms, dosage calculations, thermal control systems, and patient safety features.
• Execute risk-based testing aligned with FMEA and ISO 14971 requirements.
• Design and maintain automated GUI and regression frameworks using Squish, Selenium, Python, and Pytest.
• Integrate automated test suites with Jenkins/GitLab CI pipelines for continuous validation and release readiness.
• Improve test coverage, execution efficiency, and defect detection rates through automation initiatives.
• Perform Hardware-in-the-Loop (HIL) testing using LabVIEW, TCUs, and embedded communication interfaces.
• Validate embedded communication protocols including TCP/IP, Ethernet, UART, and serial communication.
• Use oscilloscopes, multimeters, flow meters, and J-Link debuggers for hardware/software integration testing.
• Create and maintain test cases, protocols, traceability matrices (RTM), verification reports, and defect documentation.
• Ensure compliance with IEC 62304, ISO 13485, IEC 60601/61010, IEC 62366, FDA 21 CFR Part 11, and QMS standards.
• Support FDA audits, 510(k) submissions, CAPA investigations, and post-market remediation activities.
• Participate in Agile/Scrum ceremonies and cross-functional collaboration with firmware, hardware, systems, and QA teams.
• Lead defect triage, root-cause analysis, and corrective/preventive action verification.
• Support change control and release validation activities for medical device software products.

Required Skills \& Qualifications:

• Software V\&V for medical devices and embedded systems
• Test Automation: Squish, Selenium, Python, Pytest
• CI/CD Tools: Jenkins, GitLab CI, Azure DevOps, Bitbucket
• ALM \& Traceability Tools: Jama Connect, IBM DOORS, Polarion ALM, Helix ALM
• Embedded interfaces: UART, TCP/IP, Ethernet, serial communication
• HIL testing, LabVIEW, J-Link debugger
• SQL, HTML, CSS