Software Test Engineer

Job Title

Job Description

Job title:
The Software Test Engineer is responsible for executing manual and automated test cases as outlined in the test plans created by senior team members, ensuring all tests are conducted accurately and thoroughly. The role helps maintain and review test documentation, including updating test cases and scripts based on feedback from senior testers and project requirements, ensuring all documents are current and accurate. The role participates in review sessions for test plans to understand testing objectives and contribute to discussions with insights from execution experience, enhancing the overall testing strategy. The role collaborates with developers and other stakeholders to clarify requirements and resolve issues found during testing, ensuring clear communication and effective issue resolution.

Your role:

1. Test Requirements Analysis

• Collaborate with product managers, R&D engineers, and clinical experts to understand business requirements and user scenarios in medical image processing, clinical applications, and CT console functionalities.

• Analyze core functionalities of medical image processing algorithms, CT consoles, and clinical application modules, and develop corresponding testing requirements.

• Design test cases to ensure coverage of critical features, boundary conditions, and compliance with regulatory requirements for medical devices.

2. Functional Testing

• Execute functional testing for medical image processing modules, including image reconstruction, noise reduction, artifact elimination, segmentation, and annotation features.

• Test CT console functionalities such as scan protocol configurations, image preview, patient information management, and user interaction flows.

• Validate clinical application modules (e.g., contrast enhancement analysis, bone density evaluation, lung nodule detection) to ensure they meet clinical and user needs .

3. Performance Testing

• Test the performance of image processing algorithms, including reconstruction speed, latency, and GPU/CPU resource utilization.

• Evaluate the responsiveness, concurrency handling, and reliability of console software under various workloads to ensure system stability.

• Conduct quantitative evaluations of image quality using metrics such as signal-to-noise ratio (SNR), resolution, and contrast.

4. Automation Testing Development

• Develop and maintain automated test scripts for routine functionality testing (e.g., algorithm correctness, image processing module validation) and regression testing.

• Enhance and optimize test tools and frameworks to support end-to-end testing of image processing and CT console applications.

• Design automated workflows that simulate real-world clinical scenarios .

5. Software Verification and Regulatory Compliance Testing

• Ensure that the testing process and documentation comply with medical device regulations (e.g., IEC 62304, ISO 14971, FDA 21 CFR Part 820).
• Participate in software verification activities (e.g., Design Verification, Validation Process) to meet regulatory and design control requirements.
• Conduct tests related to industry standards, such as cybersecurity (IEC 81001-5-1), reliability, and data integrity.

6. Defect Management and Optimization

• Use bug tracking tools to log, track, and resolve issues found during testing.

• Analyze root causes of defects and work closely with development teams to propose solutions and verify fixes.

• Provide actionable feedback to improve overall software stability and user experience.

7. Test Environment Setup

• Configure and maintain testing environments for medical image processing and CT console applications, including hardware emulators, imaging databases (DICOM data), and clinical test datasets.

• Create environments to simulate real-world workflows and conditions, covering typical user scenarios and edge cases.

8. Quality Control and Documentation

• Create and maintain test plans, test cases, and test reports, ensuring accurate documentation for software verification and validation.

• Ensure data and results from testing processes are traceable and meet regulatory documentation requirements.

• Support product release reviews by providing the necessary test documentation (e.g., verification and validation reports, risk evaluation).
  

You're the right fit if:

1. Educational Background

• Bachelor’s degree or higher in Computer Science, Software Engineering, Biomedical Engineering, or a related field.

• Preferred: Background in medical imaging, image processing, or the medical device industry.
  

2. Professional Skills

Technical Core Skills

• Strong knowledge of software testing principles and methodologies, including functional, performance, regression, and automated testing.

• Understanding of standards in medical device software development, such as IEC 62304 (Medical Software Lifecycle) and ISO 14971 (Risk Management).

• Proficient in using testing tools/frameworks (e.g., Selenium, Appium, Robot Framework).

• Experience with bug tracking and project collaboration tools (e.g., JIRA, Bugzilla).

• Ability to configure and validate communication between client and server for medical applications (e.g., using PACS/DICOM protocols).

Image Processing Knowledge

• Familiarity with medical imaging technologies and DICOM data, including reconstruction, noise reduction, artifact correction, and tissue segmentation.

• Knowledge of CT imaging principles and workflows, including data acquisition, image processing, and post-processing.

• Experience evaluating the robustness of image processing algorithms with diverse imaging datasets.

CT Console Testing

• Understanding of CT workflow, including scan protocol setup, user interface logic, and system integration.

• Knowledge of the interaction between CT consoles and clinical systems, such as HIS/RIS/PACS.

Automation Expertise

• Strong programming skills in Python, Java, or C++ for developing automated test scripts.

• Experience with GPU/CPU-related performance testing or optimization (e.g., CUDA-based tests).

• Familiarity with developing imaging data-specific automation tools is strongly desired .

3. Soft Skills

• Effective Communication and Collaboration Skills: Ability to clearly communicate issues and recommendations to R&D, product, and clinical teams.

• Problem-Solving Abilities: Analytical skills to identify and resolve complex functional or performance issues.

• Learning Agility: Ability and willingness to quickly learn new tools, technologies, and workflows, especially in the dynamic field of medical imaging and software.

4. Regulatory Knowledge

• Understanding of medical device regulations and compliance requirements (e.g., FDA 510(k), CE MDR processes).

• Knowledge of cybersecurity requirements for medical systems (e.g., HIPAA compliance, data encryption).

• Familiarity with quality systems for medical devices (e.g., ISO 13485).

5. Language Proficiency

• Proficiency in reading, writing, and communicating in English to work with technical documentation and create software verification reports.

• Ability to clearly articulate test observations, defect details, and resolutions.

Preferred Qualifications

• Experience: At least 3 years of testing experience in fields such as medical imaging (CT, MRI, X-ray), image processing, or PACS systems.

• AI Experience: Experience testing AI-based tools in medical imaging, such as computer-aided diagnosis or automatic lesion detection.

• Automation and Process Design: Hands-on experience with designing automated testing workflows for medical device software.