Job Title : Manual Tester – Medical Device Testing
Location : Gurugram
Experience : 3 to 7 Years
Employment Type : Full-Time
Job 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.