Senior Design Quality Engineer

3 days ago

Bengaluru Karnataka India, Karnataka Anumana Full time

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.Education and Qualification:Bachelor’s Degree or equivalent in an Engineering or other scientific discipline or combination of education and relevant work experience.4+ experience years in SaMD or SiMD medical device development, verification and validation or relevant quality experience.Experience in design verification and validation of medical devices; and understanding of and adherence to FDA, ISO and IEC design control procedures, regulations, and standards.Skills:Outstanding communication (oral and written) and interpersonal skills within all levels of the organizationAbility to manage projects efficiently and effectively.Openness to collaborate in interest of project/organization.Proactive and self-driven, possesses due sense of urgencyShall possess systems mindset and good problem-solving abilities.Benefits:Work with some of the brilliant minds of the world solving exciting real-world problems.Our benefits package includes the best of what leading organizations provide, such as stock options, paid time off, healthcare insurance, gym/broadband reimbursement.

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