Senior Design Quality Engineer
2 weeks ago
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 organization
Ability to manage projects efficiently and effectively.
Openness to collaborate in interest of project/organization.
Proactive and self-driven, possesses due sense of urgency
Shall 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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