Manual Tester – Medical Device Testing

3 - 7 years

0 Lacs

Posted:1 week ago| Platform: Linkedin logo

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Job Type

Full Time

Job Description

Job Title:

Location:

Experience:

Employment Type:

Manual Tester

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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