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
