Salary: 49.000 - 59.000 € per year Requirements: We are looking for an educational background in Computer Engineering, Software Engineering, Computer Science, Electrical Engineering, or a similar technical field. We expect solid experience with software-intensive medical devices or other regulated products. We require strong hands-on experience with design control, requirements management, risk management, and traceability. We expect proven ability to apply IEC 62304, ISO 14971, MDR / FDA guidance in practical, iterative development environments. We value experience working with or close to AI/ML development, for example as a system engineer, software engineer, algorithm developer, or technical lead. We are looking for understanding of AI-specific challenges such as data dependency, model performance, validation, change management, and lifecycle maintenance in regulated products. We expect experience with system integration and complex hardware/software interactions. We value strong analytical skills and the ability to balance technical depth with product-level decision-making. We need the ability to work independently, structure complex work, and proactively drive progress across many stakeholders. We require excellent collaboration and communication skills in a global, cross-functional environment. Experience as a software or algorithm developer is a strong advantage, but not a requirement. We require fluent written and spoken English. Some travel of 15-20% is expected. Regular presence at our Augsburg site is required. Responsibilities: We act as Release Engineer / Technical Lead for one of our core AI/ML initiatives, providing technical direction and ensuring alignment across software, algorithms, systems, and regulatory requirements. We drive the technical maturation, integration, and release of AI-powered software features into our Endoscopy Systems. We own and maintain design control deliverables, including requirements definition and traceability, as well as system and software documentation. We translate clinical, business, and regulatory needs into robust technical requirements. We ensure compliance with relevant standards and regulations, such as IEC 62304, SaMD, ISO 14971, MDR / FDA requirements, and emerging AI-related guidance and standards. We establish and maintain technical and documentation overview across system interfaces, software components, data pipelines, and model lifecycle aspects. We support regulatory submissions and audits, ensuring that documentation is complete, consistent, and aligned with our QMS. We drive lifecycle management activities, including design changes, product updates, NCRs, and CAPAs for marketed systems. We collaborate closely with Project Managers, Release Managers, Product Managers, Product Owners, AI/ML developers, testers, UX, and external partners to ensure successful delivery. We contribute to the continuous improvement of processes, templates, and ways of working supporting AI and software development in a regulated environment. Technologies: AI Hardware Support System Engineer UX UI Design Machine Learning More: We are Ambu, a global MedTech company and market leader in single-use endoscopy, growing rapidly and driven by ambitious goals, close interdisciplinary collaboration, and a strong quality mindset. Our work has real impact on products used by millions of patients worldwide, and we offer an informal, professional environment with strong opportunities for personal and professional development. This role is based in Augsburg, and we collaborate closely with colleagues across our global innovation sites, especially in Ballerup and Penang, within our global Software & Electronics organization. We offer a hybrid working model, with regular presence at our Augsburg site, and we are looking for someone motivated by meaningful work, international collaboration, and improving patient care. last updated 23 week of 2026