Senior Design Quality Engineer

As an AI-driven health technology company, Anumana is dedicated to developing cutting-edge artificial intelligence models for ECG-based diagnostics to enable early detection and intervention for heart-related diseases. By harnessing the power of AI, we aim to 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, and report out verification & validation test activities of components of a Software as a Medical Device (SaMD). - 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. - 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 to support regulatory submissions. - Support project-based activities through leading or supporting cross-functional initiatives. - Participate in continuous improvement activities by identifying and appropriately escalating process and product quality gaps. **Education and Qualification:** - Bachelors Degree or equivalent in an Engineering or other scientific discipline or a combination of education and relevant work experience. - 4+ years of experience in SaMD or SiMD medical device development, verification and validation, or relevant quality experience. - Experience in design verification and validation of medical devices; 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 the interest of the project/organization. - Proactive and self-driven, possesses a due sense of urgency. - Shall possess systems mindset and good problem-solving abilities. In addition to these responsibilities and qualifications, you will have the opportunity to work with some of the brilliant minds of the world, solving exciting real-world problems. Our benefits package includes stock options, paid time off, healthcare insurance, and gym/broadband reimbursement.,