Softwareingenieur / Softwarearchitekt – Plattformarchitektur & IVDR (m/w/d)
Core
Unify, professionalize, and rebuild a software landscape for a dementia analytics platform to ensure IVDR compliance and certifiability.
Role type
Senior Software Architect (Regulated Medical Devices)
Builds
A compliant, traceable software architecture and lifecycle for medical device analytics
Domain
Biomedical research / Medical Devices (IVDR)
Deliverable
production ML models | infrastructure
Required skills
Software architecture, regulated environment development (Medical Devices/IVD/Pharma), IVDR/IEC 62304/ISO 13485/ISO 14971 standards, complex system evaluation, software lifecycle management, technical documentation, coding/repository/branching/release standards, stakeholder alignment
Preferred skills
Traceability, software risk management, verification and validation processes, embedded software/firmware, Python data processing pipelines, CI/CD/Docker, automated testing, cybersecurity, software supply chain, legacy system modernization
Responsibilities
Analyze and evaluate existing software components and dependencies; Develop and evolve a target architecture; Define module boundaries, interfaces, data models, and data flows; Prioritize refactoring, modernization, and rewrite efforts; Create a migration and evolution strategy; Define architecture principles and technical standards; Support implementation of regulatory requirements (IVDR, IEC 62304, ISO 13485, ISO 14971); Build a traceable software lifecycle; Establish end-to-end traceability from requirements to verification; Create consistent technical documentation; Standardize coding and release standards; Moderate and document architecture decisions; Align technical decisions with stakeholders
Seniority
Senior, hands-on IC with strategic oversight
