System Test Engineer

Job Title

Job Description

Job title:
System Test Engineer

Roles & Responsibilities

1. Clinical Validation & Workflow Testing

• Validate medical software against real-world clinical workflows .
• Ensure test cases align with clinical scenarios and patient use cases .
• Work with clinicians to verify that software meets clinical decision-making needs .

2. Test Planning & Execution

• Design and execute test cases based on medical guidelines and clinical workflows .
• Perform functional, usability, and interoperability testing for healthcare applications.
• Test medical imaging systems, electronic health records (EHRs), AI-based diagnostics, and decision-support systems.

3. Compliance & Regulatory Testing

• Ensure software complies with healthcare regulations like FDA (21 CFR Part 820), HIPAA, MDR (EU), ISO 13485, and IEC 62304 .
• Validate data privacy, security, and audit trails in compliance with medical standards.

4. Clinical Risk Assessment

• Identify potential patient safety risks due to software issues.
• Work with risk management teams to implement mitigation strategies .
• Support Failure Mode and Effects Analysis (FMEA) for clinical features.

5. Interoperability & Integration Testing

• Test software integration with medical devices, imaging systems (DICOM, PACS), and hospital information systems (HIS, LIS, RIS) .
• Validate HL7, FHIR, and other healthcare data exchange standards.

6. User Experience (UX) & Human Factors Testing

• Ensure software is clinician-friendly and aligns with usability standards .
• Conduct usability studies and collect feedback from healthcare professionals.

7. Clinical Data Validation & AI Model Testing

• Verify correctness of clinical algorithms, AI-driven diagnostics, and predictive models .
• Validate sensitivity, specificity, and accuracy of AI-based recommendations.

8. Defect Triage & Collaboration with Developers

• Work closely with developers, product managers, and clinical SMEs to resolve issues.
• Provide clinical context to help developers fix defects effectively.

9. Training & Documentation

• Document test cases, clinical validation reports, and regulatory compliance results .
• Provide training for test teams and developers on clinical workflows and requirements.

10. Supporting Customer & Field Testing

• Participate in beta testing, UAT, and live clinical environment validations .
• Assist in investigating customer-reported clinical issues .

Key Skills Required

• Knowledge of clinical workflows, medical imaging, EHRs, and healthcare regulations .

• Experience in test planning, automation, and regulatory testing .
• Understanding of HL7, FHIR, DICOM, and interoperability .
• Collaboration with clinicians, developers, and regulatory teams .