Systems/Release Engineer / Technical Lead

As Release Engineer / Technical Lead for AI & ML, you shape the safe, regulated integration of AI-enabled features into Ambu’s Endoscopy Systems. You act as the technical anchor between AI/ML developers, systems, and regulatory affairs to ensure compliant, scalable releases. You work across software, algorithms, and hardware interfaces, balancing technical depth with patient-safety priorities. The role combines design control with lifecycle management in a global, cross-functional setting, offering meaningful impact on patient care and product maturity.

• hybrid working model
• global collaboration
• opportunities for personal and professional development

• Provide technical direction as Release Engineer / Technical Lead for core AI/ML initiatives
• Drive maturation, integration, and release of AI-powered software features
• Own design control deliverables: requirements definition/traceability, system/software documentation
• Translate clinical, business, and regulatory needs into robust technical requirements
• Ensure compliance with IEC 62304, ISO 14971, MDR/FDA guidance and AI-related standards
• Maintain technical/documentation overview across systems, software, data pipelines, and model lifecycle
• Support regulatory submissions and audits ensuring documentation aligns with QMS
• Lead lifecycle management activities: design changes, NCRs, CAPAs for marketed systems
• Collaborate with PMs, Release Managers, Product Managers, AI/ML teams, testers, UX, and external partners
• Contribute to process improvements for AI/software development in regulated environment
• Travel 15-20% for global collaboration

• Educational background in Computer Engineering, Software Engineering, Computer Science, Electrical Engineering or similar
• Solid experience with software-intensive medical devices or regulated products
• Strong hands-on experience with design control, requirements management, risk management, and traceability
• Proven ability to apply IEC 62304, ISO 14971, MDR/FDA guidance in practical development
• Experience with AI/ML development or proximity to AI/ML teams
• Understanding of AI-specific challenges in regulated products (data, validation, lifecycle maintenance)
• Experience with system integration and complex hardware/software interactions
• Strong analytical skills and ability to balance depth with product decisions
• Ability to work independently and drive progress across stakeholders
• Excellent collaboration and communication in a global, cross-functional environment
• English proficiency (written and spoken)

• collaboration
• communication
• analytical thinking
• AI/ML development exposure
• design control
• requirements management