Job Summary

• Lead and manage end-to-end testing activities for medical device software (embedded + system level)
• Define and drive test strategy, test plans, and V&V approach
• Ensure compliance with medical device standards (IEC 62304, ISO 14971, ISO 13485)
• Collaborate with R&D, systems engineering, regulatory, and quality teams
• Oversee test case design, execution, and defect management
• Validate hardware–software interaction scenarios in complex systems
• Drive automation strategy where applicable (API / embedded / system testing)
• Ensure proper documentation of:
• Test protocols
• Verification reports
• Traceability matrices
• Lead test estimations, sprint planning, and release readiness
• Conduct peer reviews of technical and verification documents
• Mentor team and ensure adherence to quality processes and QMS

Key Responsibilities

1. To participate in functional as well as technical discussions with the client /team to understand functional /design specifications ,highlight performance concerns, inconsistencies ,ensure the appropriate test environments and infrastructures are in place/kept upto date.
2. To Identify opportunities for process improvement in testing methodologies /tools and Implement best practices to enhance the efficiency and effectiveness of the testing process.
3. To oversee the creation and execution of automated test scripts ensuring consistency and alignment with quality standards to minimize exposure.
4. To develop/guide and mentor QA engineers in the use of the testing framework , enhancing their technical capabilities and increasing productivity.

Skill Requirements

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Other Requirements

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