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Job Description
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
