What are the responsibilities and job description for the Software Test Method Validation (TMV) position at Katalyst CRO?
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
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.
- 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