Network-System Analyst System Engineer (Medical Device / SaMS)

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Network/System Analyst - System Engineer (Medical Device / Software as a Medical Device) m/f For my client, a global leader in Life Science, I am currently looking for a specialist in System Engineering, with experience in covering the product development to the life cycle management and experience as a network architect for their medical device development projects. The expert will work with cross-functional teams and support various development activities including system conceptualization, system requirements, risk assessment, system verification and validation. Location: Basel, SwitzerlandDuration: Start mid July, 12 months with possible extensionDepartments: Packaging and Device Development (PDD) departmentActivities: Support the development and life cycle management of complex products as well as software as medical device

Network/System Analyst - System Engineer

Main Responsibilities Design and implement system engineering approach to support the development and life cycle management of complex products and platforms in the areas of connected drug delivery devices, digital technologies, and SaMDDemonstrate strong technical know-how at system level and guide the development team to use structured system engineering approach for product developmentUtilize the system engineering tool for requirement management and translate user and business needs into system/sub-system requirementsActively maintain and monitor the traceability from the requirements to the verification activitiesBe the representative of system engineering for the communications with cross-divisional teams, programs, and stakeholdersManage external vendors for development and lead the technical discussions with the vendorsAuthor relevant design history files and GMP compliant documentations Qualification The profile Bachelor or more advanced degrees in Biomedical Engineering, Systems Engineering, Electrical Engineering, Computer Science, or other relevant disciplinesMinimum of 5 years experience in network architectureKnowledge in system functional modeling and/or programming ability using system modeling language (SysML) will be a plusWell-versed in medical product development, Quality Management System, and regulatory processes (ISO 13485; IEC 60601, 62304, 82304)Experience in developing and commercializing products using artificial intelligence or machine learning models is a strong advantageA good team player, and problem solver with strong analytical mindStrong communication skills to both lead the technical discussions with vendors and also align with internal stakeholders to drive decisions Should you be interested in a project in Switzerland? Kindly get in contact with me and send me your updated CV to m.becker(at)realstaffing.com or give me a call on +41 (0) 44 588 2669.Sthree Switzerland is acting as an Employment Business in relation to this vacancy.