Software Test Method Validation; TMV

Position: Software Test Method Validation (TMV)
Job-ID Reference
26-00635

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/Git Lab 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, PytestCI/CD Tools:
Jenkins, Git Lab CI, Azure Dev Ops, BitbucketALM & Traceability Tools:
Jama Connect, IBM DOORS, Polarion ALM, Helix ALMEmbedded interfaces: UART, TCP/IP, Ethernet, serial communicationHIL testing, LabVIEW, J-Link debuggerSQL, HTML, CSS