Manual Tester - Medical Device Testing

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.