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Software Test Method Validation (TMV)

Katalyst Healthcares & Life Sciences

South Plainfield, NJ

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JOB DETAILS
SKILLS
Agile Programming Methodologies, Automation, Bug Tracking/Defect Management, Change Control, Code of Federal Regulations, Communications Protocols, Computer Firmware, Continuous Deployment/Delivery, Continuous Integration, Control Systems, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Debugging Tools, DevOps, Documentation, Embedded Software, Embedded Systems, Ethernet, FDA (Food and Drug Administration), Failure Mode and Effects Analysis (FMEA), Flow Meter, Functional Testing, Graphical User Interface (GUI), Hardware Debugging, Hardware-Software Integration, Healthcare Software, Hemodialysis, IBM Product Family, ISO (International Organization for Standardization), Infusion Pumps, Integration Testing, International Electro-Technical Commission (IEC), Jenkins, LabVIEW Programming Language, Maintain Compliance, Medical Equipment, Medical Products, Microsoft Windows Azure, Oscilloscope, Patient Safety, Polymerase Chain Reaction (PCR), Pytest, Python Programming/Scripting Language, Quality Assurance, Quality Assurance Methodology, Regression Testing, Regulations, Risk, Root Cause Analysis, Scrum Project Management and Software Development, Selenium, Software Administration, Software Debugging, Software Testing, Software Validation, System Test, Systems Engineering, Systems Maintenance, TCP/IP (Transmission Control Protocol/Internet Protocol), Test Automation, Test Case, Test Plan/Schedule, Test Strategy, Test Suite, Testing, Thermal Management, Traceability, Universal Asynchronous Receiver-Transmitter (UART), Validation Testing, Verification Engineering
LOCATION
South Plainfield, NJ
POSTED
30+ days ago
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

About the Company

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Katalyst Healthcares & Life Sciences

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