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Senior Medical Software Architect / System Engineer (m/f/d)
As leading Senior Medical Software Architect / System Engineer (m/f/d) you are supporting the digital transformation of the Bayer Pharmaceutical product portfolio through the design and development of innovative eHealth & medical software systems. You are ensuring the scientifically adequate verification, technical validation and clinical evaluation of eHealth & Medical Software Systems classified as Medical Devices by external manufacturers as well as the architectural integration of eHealth & Medical Software Solutions into the digital ecosystem orchestrated by Bayer Pharmaceutical.
YOUR TASKS AND RESPONSIBILITIES
- Focus on design, conception and evaluation of software architectures for solutions classified as medical device according to the current state of art and in compliance with the applicable standards and legislation
- Definition of the technical proof of concept studies / pilots for complex medical algorithms / solutions including the selection of adequate test methods
- Independent monitoring of verification and validation activities of the external development partner in compliance with industry standards
- Supports interdisciplinary Medical Software Product Teams by defining “Minimal Viable Product” specifications
- Ensuring the oversight of external suppliers or service partners in the context of system architecture implementation and system integration in healthcare IT ecosystems
- Creation / revision of technical registration documents (TRDs) for eHealth components of combination products as well as coordination of the creation / revision of TRDs and other documents such as certificates that are created by internal or external partners
- Conception and implementation of the data interfaces between Bayer and external partners for the exchange of sensitive health data in compliance with data protection guidelines and Bayer internal compliance standards
WHO YOU ARE
- University degree (master or PhD) in computer science or equivalent subjects with significant hands-on experience & background in software architecture and/or system engineering
- Professional background in the regulated industry field (e.g. ISO 13485, IEC 62304, ISO 14971) with long-term practical experience in the field of software as Medical Device development
- Experience with requirements engineering methods and tools, DevOps, automated V&V, integration testing and tool validation
- Experience with mobile and cloud-based software architectures; front- and backend technology stacks (modern dynamic web technologies and embedded software architecture, is a plus)
- Knowledge of digital signal processing algorithms and/or machine learning
- Knowledge of cyber-security and data protection compliance requirements, standards, best practices and incident management
- Distinct conceptual and result-oriented thinking as well as customer orientation, high flexibility and resilience, mobility for travel up to 15%
- Work experience in an international environment
- Fluent language skills (spoken and written) in English are a must
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Standort: Deutschland : Berlin : Berlin