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Manual Tester – Medical Device Testing
Manual Tester – Medical Device TestingL&T Technology Services • haryana, haryana, in
Manual Tester – Medical Device Testing

Manual Tester – Medical Device Testing

L&T Technology Services • haryana, haryana, in
6 days ago
Job description

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.
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    Manual Tester • haryana, haryana, in

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