Technical Lead - Software as Medical Device

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For our Medical Device Company we are recruiting for an expert in App Development to support their expanding development of "Software as a Medical Device" (SaMD),You will be a recognized expert for the development and maintenance of safety critical mobile and/or web applications and will take over the technical leadership for the software development part for projects classified as SaMD within the Packaging & Device Development Team.Responsibilities:The role includes early phase development activities, the management and monitoring of software development at external partners, and the commercialization and maintenance of overall life cycle management as legal manufacturer.Technical leadership for the software development of mobile and/or web applications classified as SaMDProviding software/systems life cycle expertise within a broader cross?functional drug product development teamSupporting the standardization of the entire SaMD life cycle management process in order to utilize cross?product synergiesLeading the collaboration with external development partners:

o Support supplier selection, auditing and approval

o Elaboration of development plans and contracts for upcoming projects

o Monitor work progress according to plan

o Monitor, support and challenge technical development and deliverables as well as change, test and release strategies

o Support the deployment and implementation of a sustainable Product Life Cycle process in close collaboration with external and internal partners and stakeholdersLeading and/or supporting cross functional project teams during development, review and submission of regulatory dossiersLeading risk management activitiesPlanning and monitoring of design verification activitiesLeading and authoring technical documentationEnsuring a high quality Design History FileSupporting the improvement of the SaMD QMS Requirements: MSc/MA in computer science or relevant field and excellent understanding of the current Agile development methodsand technologiesExperience in project / program management of complex projectsAutonomous and independent working style with at least 7 years of experience as technical project management of projects with safety critical applications in a regulated environmentTeam player who works efficiently in interdisciplinary teamsExperience in designing innovative software and systems architecturesAnalytical thinking and problem?solving capabilityExcellent understanding of software design and programming principles as well as in overall verification strategies, including test set?up and test automationConsiderable experience of managing external suppliersGeneral understanding of Human Factors Engineering, risk management and clinical studies processes and requirements

Understanding of medical device regulations (FDA 21CFR 820, FDA 21CFR Part 4, EU Medical Device Directive, EU Medical Device Regulation), including those related to medical software (IEC 62304) Kontact: or call +41 (0) 44 215 2051 Michael Bailey International is acting as an Employment Business in relation to this vacancy.