SaMD Network/System Analyst - System Engineer
RM IT Professional Resources AG
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System Engineer / Software Architect vacancy for our Basel based globally operating client in the pharmaceutical sector.Your experience/skills:Minimum 5 years of experience in medical device or other regulated industry with expertise in Web and Mobile application design using UML/SysML diagrams, development and testingSound knowledge of the best methodologies (Agile and V-Model) and tools (CI/CD, Automation, Requirement Management) for software development, along with experience with user experience, prototypes and proof of concept activitiesStrong understanding of Cloud and IoT architecture and technologies for complex systems, as well as experience with cyber security, data privacy and system performance requirementsProficiency in medical device or SaMD development, Quality Management System, and regulatory processes (ISO 13485; IEC 60601, 62304, 82304)Previous experience in carrying out full-cycle expansion of medical device or SaMD developmentBachelor or higher degree in Biomedical Engineering, Systems Engineering, Electrical Engineering or other relevant disciplinesLanguages: English, fluent in written and spokenYour tasks:Designing and implementing 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 SaMDDemonstrating strong technical know-how at system level and guiding the project teams for product developmentUtilizing the system engineering tool for requirement management and translating user and business needs into system/sub-system requirementsMaintaining and monitoring the traceability from the requirements to the verification activitiesBeing the representative of system engineering team for the communications with cross-divisional teams, programs, and stakeholdersManaging external vendors for development, as well as taking the lead on technical discussionsAuthoring relevant design history files and GMP compliant documentationsSupporting various development activities including system conceptualization, system requirement definition, risk assessment, system verification and clinical validation
BH15943Does this spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.Going the Extra Mile.As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day.Due to work permit restrictions we unfortunately can only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.New to Switzerland? In case of a successful placement, we support you with:All administrative questionsFinding an apartmentHealth- and social insuranceWork permit and much more Thank you for your interest. By applying, you give us the permission to internally store and process your data for the application process. We strictly comply with the applicable data protection laws.