Location: Pune
Experience: 3–5 Years
We are looking for a detail-oriented Manual QA Engineer with experience in the Medical Devices domain to join our engineering team in Pune. The ideal candidate should have hands-on experience in manual software testing, a strong understanding of software quality assurance processes, and exposure to AI-powered testing tools or AI-enabled healthcare applications. Experience working in regulated environments and familiarity with medical standards is highly desirable.
- Design, develop, and execute manual test cases based on functional and system requirements.
- Validate software applications used in medical devices and healthcare solutions.
- Perform functional, regression, integration, system, and exploratory testing.
- Identify, document, track, and verify software defects using defect management tools.
- Collaborate with developers, business analysts, and product owners to understand requirements and ensure product quality.
- Participate in requirement reviews and provide inputs for testability and quality improvements.
- Support verification and validation (V&V) activities for medical device software.
- Ensure compliance with software development and quality processes in regulated environments.
- Utilize AI-powered testing tools (such as GitHub Copilot, ChatGPT, Microsoft Copilot, or similar AI assistants) to improve test case creation, documentation, defect analysis, and productivity.
- Contribute to continuous improvement of QA processes and testing methodologies.
- 3–5 years of experience in Manual Software Testing.
- Experience testing Medical Device or Healthcare software applications.
- Strong knowledge of Software Testing Life Cycle (STLC) and Software Development Life Cycle (SDLC).
- Experience in writing test scenarios, test cases, and executing test plans.
- Good understanding of Functional, Regression, Integration, System, and User Acceptance Testing.
- Experience with defect tracking tools such as Jira or Azure DevOps.
- Basic understanding of SQL for database validation.
- Excellent analytical, debugging, and communication skills.
Experience with one or more of the following is preferred:
- Medical Device Software Testing
- DICOM
- HL7/FHIR
- PACS/RIS
- FDA regulations
- IEC 62304
- ISO 13485
- Verification & Validation (V&V)
- Hands-on experience using AI-assisted development/testing tools such as GitHub Copilot, ChatGPT, Microsoft Copilot, or similar.
- Experience leveraging AI for:
- Test case generation
- Test data creation
- Requirement analysis
- Defect analysis
- Test documentation
- Understanding of AI/ML-enabled healthcare or medical device applications is an added advantage.
- Bachelor's degree in Computer Science, Electronics, Biomedical Engineering, or a related field.
- Experience working in Agile/Scrum environments.
- ISTQB Certification is a plus.
- Exposure to basic automation testing concepts.
- Knowledge of API testing using Postman.
- Experience with risk-based testing in regulated environments.
- Familiarity with cloud-based healthcare applications.
This role is ideal for a QA professional who combines strong manual testing expertise with medical device domain knowledge and an interest in using AI tools to improve software quality and testing efficiency.
