Medical Device Testing Specialist

4 days ago

Gurgaon, India beBeeManualTester Full time

Job Title: Manual Tester – Medical Device ExpertiseWe are seeking a detail-oriented Manual Tester with extensive experience in Medical Device Testing to collaborate on our Gurugram project. The ideal candidate will possess 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.Main Responsibilities:- Design, develop, and execute comprehensive manual test cases based on software requirements and specifications.- Perform thorough functional, regression, integration, and system testing on embedded medical devices and related software.- Document and track defects using specialized tools like JIRA or Bugzilla.- Collaborate closely with cross-functional teams including developers, product managers, and regulatory experts.- Ensure compliance with medical device standards such as IEC 62304, ISO 14971, and FDA guidelines.- Participate actively in risk analysis, traceability matrix creation, and test documentation.- Support verification and validation (V&V) activities for software releases.Required Skills and Qualifications:- 3–7 years of experience in manual testing, preferably in the medical device domain.- Strong understanding of Software Development Life Cycle (SDLC), System Test Life Cycle (STLC), and defect life cycle processes.- Experience with test management tools (e.g., HP ALM, Test Rail).- Familiarity with regulatory standards like IEC 62304, ISO 13485, and FDA 21 CFR Part 11.- Excellent analytical and problem-solving skills.- Strong communication and documentation skills.Benefits and Opportunities:- Collaborative work environment with opportunities for growth and professional development.- Participation in industry-leading projects and contributions to innovative solutions.About the Role:- This is an exciting opportunity to join our team as a skilled Manual Tester with expertise in Medical Device Testing. If you are passionate about ensuring the quality and reliability of medical devices, we encourage you to apply.

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