Manual Tester – Medical Device Testing

Job Title: Manual Tester – Medical Device TestingLocation: GurugramExperience: 3 to 7 YearsEmployment Type: Full-TimeJob Description:We are seeking a skilled and detail-oriented Manual Tester with experience in Medical Device Testing to join our team in Gurugram. The ideal candidate will have a strong background in manual testing methodologies, regulatory compliance (such as IEC 62304), and a passion for ensuring the safety and reliability of medical devices.Key Responsibilities:- Design, develop, and execute manual test cases based on software requirements and specifications. - Perform functional, regression, integration, and system testing on embedded medical devices and related software. - Document and track defects using tools like JIRA or Bugzilla. - Collaborate with cross-functional teams including developers, product managers, and regulatory teams. - Ensure compliance with medical device standards such as IEC 62304, ISO 14971, and FDA guidelines. - Participate in risk analysis, traceability matrix creation, and test documentation. - Support verification and validation (V&V) activities for software releases.Required Skills:- 3–7 years of experience in manual testing, preferably in the medical device domain. - Strong understanding of SDLC, STLC, and defect life cycle. - Experience with test management tools (e.g., HP ALM, TestRail). - Familiarity with regulatory standards like IEC 62304, ISO 13485, and FDA 21 CFR Part 11. - Good analytical and problem-solving skills. - Excellent communication and documentation skills.Preferred Qualifications:- Experience in embedded systems or firmware testing. - Knowledge of automation tools (e.g., Selenium, Robot Framework) is a plus. - ISTQB certification or equivalent is an advantage.

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