Test Engineer II

Top 3 technical skills that are required for the role:

• Knowledge of Verification and Validation Processes and Test Method Validation Experience.
• Technical Writing and Documentation
• Attention to detail

Education Required: 2 yrs with university degree

Years’ Experience

Required:

University Degree and minimum of 2 years of relevant experience

The Medical Device Software Verification & Validation Engineer is responsible for planning, executing, and documenting software testing, test method validation, and verification and validation activities for regulated medical devices. This role ensures that software and associated test methods meet design specifications, product requirements, risk controls, and applicable quality and regulatory standards. The engineer collaborates with cross-functional partners across Research and Development, Quality, Manufacturing, and Regulatory functions to deliver reliable, compliant, and audit-ready results.

• Plan and execute verification and validation activities to demonstrate that medical device software meets approved design inputs, functional requirements, performance expectations, and regulatory requirements.
• Develop, review, and execute V&V protocols; analyze results; investigate anomalies; and prepare clear, technically sound reports.
• Conduct black-box, white-box, integration, and system-level testing for embedded systems and medical device software.
• Maintain bidirectional traceability among software requirements, identified risks, test cases, test results, defects, and corrective actions.
• Partner with Research and Development and Quality teams to troubleshoot and resolve issues identified during testing.

• Develop and execute Test Method Validation protocols to confirm that test methods are accurate, repeatable, reproducible, and suitable for their intended use.
• Perform Gauge R&R studies, analysis of variance, and other statistical analyses to evaluate measurement system performance and test method capability.
• Define acceptance criteria based on engineering requirements, product risk, intended use, and applicable regulatory expectations.
• Identify sources of variation, troubleshoot test method issues, and recommend corrective actions that improve reliability and consistency.
• Collaborate with stakeholders to align test methods with product design, software development, and manufacturing needs.
• Prepare comprehensive validation reports that support audits, design control documentation, and regulatory submissions.

• Work with cross-functional teams to identify product and process risks and implement appropriate mitigation strategies.
• Integrate risk controls and risk-based testing into V&V and TMV planning and execution.
• Document risk assessments and maintain traceability between identified hazards, risk controls, verification evidence, and mitigation actions.

• Bachelor’s degree in software engineering, electrical engineering, biomedical engineering, computer science, or a related technical discipline, or equivalent relevant experience.
• Experience with software testing, verification and validation, or test method validation in a regulated product-development environment.
• Working knowledge of software testing methodologies, requirements traceability, defect management, and design controls.
• Demonstrated ability to apply statistical methods, interpret data, troubleshoot technical problems, and communicate results through clear technical documentation.

• Verification and validation planning and execution
• Test method validation and statistical analysis
• Software testing, debugging, and defect investigation
• Risk assessment and requirements traceability
• Technical writing and regulatory compliance
• Data interpretation, analytical thinking, and structured problem-solving
• Cross-functional collaboration and clear communication
• Continuous improvement and engineering innovation