Lead software as medical device team

3 settimane fa

Roma, Lazio, Italia Cosmo Intelligent Medical Devices A tempo pieno

About the Company: Cosmo IMD is a division of the Cosmo Pharmaceutical group focusing on medical devices integrating artificial intelligence. Cosmo IMD has developed in recent years unrivaled expertise in multiple aspects related to the AI Med Tech business, such as medical device Hardware and Software design, healthcare Artificial Intelligence development, medical data harvesting, clinical development, scientific production, and regulatory expertise in the US and worldwide. Cosmo IMD team is manufacturing GI Genius, the world's first real-time artificial intelligence medical device that is globally distributed by Medtronic.About the Role: We are looking for a Lead the SAMD (Software as Medical Device) TeamResponsibilities: Create an inspiring team environment with an open communication culture;Set clear team goals;Motivate team members;Oversee day-to-day operation;Discover training needs and provide coaching;Encourage creativity and risk-taking;Design, develop and maintain SW as Medical Device;Proactively collaborate with other teams (electronics, AI, mechanical, quality);Create and iterate user needs, risk management, and product requirements while identifying plans for verification and validation;Identify and mitigate project risks;Interface with internal and external suppliers, manufacturers, and customers;Work collaboratively with project teams and engineering skillsets through all stages of development. Qualifications: Full understanding of Design ControlC and C++ are a must (at least 3 years development experience)Python and Bash are a plusBasic knowledge of computer architectureBasic knowledge of operating systems and in particular LinuxKnowledge of system libraries and the Posix standardAbility to design and develop data structuresKnowledge of the main compilation toolsAbility to compile third-party libraries, archives, etc.Ability to integrate proprietary software with third-party softwareKnowledge of computational complexityAbility to analyze problems and synthesize algorithmsMulti-threaded application design and developmentKnowledge of key synchronization techniques and toolsDesign and development of modules for the Linux kernelKnowledge of medical device specialization with a strong understanding of electronic-based technologiesDemonstrated ability to effectively engage key StakeholdersEffectively utilize problem-solving skills and techniques to identify potential issues, assess their impact, and develop and implement mitigation and resolution plans and activitiesAbility to work under stress and under time constraints. MINIMUM REQUIRED EDUCATION AND EXPERIENCE: Master Degree in Physics, Mathematics, Computer Science, or Software Engineering (Ph D is a plus).At least 5 years of experience with C and C++ (mainly standard library), and basic knowledge of Python and Bash. Experience with GPU programming (CUDA) is a plusKnowledge of ISO, regulatory and legislative standards applicable to the development of medical devices;Fluent English, written and spoken;Knowledge of ISO, regulatory and legislative standards applicable to the development of medical devices is a plus. PREFERRED QUALIFICATIONS: Knowledge of IEC/EN 60601-1 and IEC/EN 60601-1-2;Knowledge of 2017/745(MDR) and 21 CFR 820;Knowledge of 21 CFR part 11;Ability to write and review all project related Documentation (FRS, SRS, SDS, HRS, HDS, etc.)Basic experience on programming languagesBasic experience with the Linux environment; Physical Requirements: Expected travel is 30%Equal Opportunity Statement: We support equal opportunities, without any discrimination; The research complies with Legislative Decree 198/2006

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