Medical Device Testing

JD- Medical Device Testing

Note- This is a Direct contract role

• Execute functional, integration, system, and regression testing of medical devices and associated software.
• Verify that medical devices operate according to specified requirements.
• Perform testing based on approved test plans, test cases, and protocols.
• Identify, document, and report defects with clear steps to reproduce.

2. Test Planning and Documentation

• Assist in preparing test cases, test scenarios, and test data.
• Maintain test execution reports and defect-tracking records.
• Prepare test summary reports and maintain accurate testing documentation.
• Ensure test results are traceable to product requirements.

3. Defect Management

• Log and track defects using tools such as Jira or Azure DevOps.
• Collaborate with developers and QA engineers to investigate and resolve issues.
• Perform retesting and regression testing after defect fixes.

4. Quality and Regulatory Compliance

• Follow established quality procedures and testing guidelines.
• Understand the basics of medical device standards, including ISO 13485.
• Support documentation and verification activities required for regulatory compliance.
• Follow risk-based testing practices to help ensure device safety and reliability.

5. Collaboration and Continuous Improvement

• Work closely with development, QA, hardware, and regulatory teams.
• Participate in test reviews and defect triage meetings.
• Contribute to improving testing processes and methodologies.

Required Qualifications

• Bachelor's degree or diploma in Biomedical, Electronics, Electrical, Instrumentation, Computer Science, or a related engineering discipline.
• 34 years of experience in software testing, medical device testing, or a related QA role.
• Good understanding of functional, regression, and integration testing.
• Experience in test case preparation, test execution, and defect reporting.
• Basic understanding of medical device quality and regulatory standards.
• Strong analytical, problem-solving, documentation, and communication skills.

Preferred Qualifications

• Knowledge of ISO 13485, ISO 14971, IEC 62304, or FDA medical device regulations.
• Familiarity with Jira, Azure DevOps, or other defect-tracking tools.
• Exposure to hardware-software integration testing or medical device verification and validation.

Key Skills

• Manual testing
• Test case design and execution
• Defect tracking and reporting
• Medical device verification and validation
• Test documentation and traceability
• Medical device regulatory awareness
• Analytical and communication skills