Medical Device Engineer / Senior Medical Device Engineer

nFerence Labs: AI platform to reverse engineer biological systems At nFerence Labs, the "Google of Biomedicine" (See nference.ai/media ), where we are building the world's first large-scale computational platform for reverse engineering biology. Just as 20th-century science comprised of the deconstruction of physics unlocking all the engineering and tech applications we are so familiar with, this century is witnessing the deconstruction or reverse engineering of biological systems to unlock all kinds of medical and wellness applications. We collaborate heavily with premier medical research institutions to get medical insights from patient information including multiple modalities: text, lab data, images, ECGs, etc. See also anumana.ai our affiliated company developing cardiology AI; where we are conducting clinical studies for cardiovascular algorithms. Our team is a blend of computer scientists and domain experts (biology and medical MDs, and PhDs from premier universities), and we provide an exciting open fast-paced dynamic workplace designed to foster innovative solutions. Responsibilities: Participate in cross functional teams supporting software design and development lifecycle. Author, execute, perform, summarize, 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. Support development projects meet defined development process requirements of FDA 21 CFR 820.30, EN/ISO 13485:2016 and IEC 62366-1. Support software development is compliant with IEC 63204:2015 standard. Participate in the development of risk management activities for projects in compliance with ISO 14971:2019. Support the developmental design change process for each project's specifications. Actively participate in non-product software tool evaluation and validation process. Support project-based activities and cross-functional initiatives. Education and Qualification: Bachelor’s Degree or equivalent in an Engineering or other scientific discipline or combination of education and relevant work experience. 3+ 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 a basic understanding of FDA, ISO and IEC design control procedures, regulations, and standards. Skills: Outstanding communication (oral and written) and interpersonal skills Openness to collaborate in interest of project/organization. Detail oriented Proactive and self-driven, possesses due sense of urgency Shall possess systems mindset and good problem-solving abilities.