Medical Device Testing

Impelsys; Bengaluru; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Impelsys in Bengaluru seeks a direct-contract QA tester for medical devices. You will execute functional, integration, system, and regression tests on medical devices and related software, ensuring operation per requirements.

Responsibilities include planning, documenting test results, defect reporting, and collaboration with development and regulatory teams to ensure traceability and compliance. Strong communication and regulatory awareness are essential.

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.

Responsibilities

• 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.

Skills

Manual testing

Test case design

Defect tracking

Medical device verification

Test documentation

Regulatory awareness

Analytical skills

Communication skills

Education

Biomedical/engineering degree or diploma

Tools

Jira

Azure DevOps

Job description

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