Manual Tester – Medical Device Testing

• 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.
• Support verification and validation (V&V) activities for software releases.
• Document and track defects using tools like JIRA or Bugzilla.
• Perform functional, regression, integration, and system testing on embedded medical devices and related software.
• Participate in risk analysis, traceability matrix creation, and test documentation.
• Design, develop, and execute manual test cases based on software requirements and specifications.

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.

Experience: 3 to 7 Years

• Excellent communication and documentation skills.
• ISTQB certification or equivalent is an advantage.
• Strong understanding of SDLC, STLC, and defect life cycle.
• Experience with test management tools (e.g., HP ALM, TestRail).
• Experience in embedded systems or firmware testing.
• Good analytical and problem-solving skills.
• Familiarity with regulatory standards like IEC 62304, ISO 13485, and FDA 21 CFR Part 11.
• 3–7 years of experience in manual testing, preferably in the medical device domain.
• Knowledge of automation tools (e.g., Selenium, Robot Framework) is a plus.