Senior Design Quality Engineer

About Anumana :

Anumana is a new AI-driven health technology company developing cutting-edge artificial intelligence models for ECG-based diagnostics. Our advanced algorithms leverage ECG, scans, and other inputs to enable early detection and intervention for heart-related diseases. By harnessing the power of AI, we empower healthcare providers to enhance patient care at every stage of the cardiac journey.

Responsibilities :

• Participate in cross-functional teams supporting software design and development lifecycle.
• Author, execute, perform, summarise, report out verification & validation test activities of components of a Software as a Medical Device (SaMD); which includes but not limited to : Test Plans, Test Procedures, User and Functional Requirements testing, Design Verification, Traceability Matrices, and Final Reports.
• Ensure development projects meet defined development process requirements of FDA 21 CFR 820.30, EN / ISO 13485 : 2016 and IEC 62366-1.
• Ensure software development is compliant with IEC 63204 : 2015 standard.
• Facilitate the development of risk management activities for projects in compliance with ISO 14971 : 2019.
• Ensure timely completion of all deliverables to support the design and development projects.
• Share expertise with and support the developmental design change process for each project's specifications.
• Actively participate in non-product software tool evaluation and validation process.
• Ensure the quality of all design and development documents and records, so that they readily support regulatory submissions.
• Support project-based activities through leading or supporting cross-functional initiatives.
• Participates in continuous improvement activities by identifying and appropriately escalating process and product quality gaps.

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