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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Senior Risk Manager Azurion Eye - AI, cloud, Sa(N)MD - **Company:** Koninklijke Philips N.V. - **Location:** AMSTERDAM, Netherlands - **Experience:** Expert - **Salary:** €6,516.0 - €10,859.0 - **Contract:** Permanent contract - **Skills:** Agile Methodology, Artificial Intelligence, Amazon Web Services, Systems Engineering, Computer Vision, Microsoft Azure, Cloud Engineering, Continuous Integration, Dicom, Distributed Systems, Machine Learning, Performance Tuning, Software Engineering, Fast Healthcare Interoperability Resources, Large Language Models, Containerization, Kubernetes, Information Technology, Health Level Seven International, Machine Learning Operations, Devsecops - **Published:** September 2, 2026 - **Apply:** https://philips.wd3.myworkdayjobs.com/jobs-and-careers/job/Best/Senior-Risk-Manager--Azurion-Eye----AI--cloud--Sa-N-MD_588506-1 ## About the Role * A Master's or PhD in Biomedical Engineering, Systems Engineering, Software Engineering, Computer Science, or a related field. * At least 8 years of experience in regulated medical device development. * Extensive experience leading risk management for software-intensive medical devices. * Experience with AI-enabled SaMD, connected healthcare systems, cloud-native software, and distributed architectures. * Strong knowledge of ISO 14971, IEC 62304, IEC 82304-1, ISO 13485, IEC 81001-5-1, FDA QMSR, and EU MDR. * Experience with cybersecurity risk management, regulatory submissions, audits, and post-market surveillance. * Strong stakeholder management skills and the ability to influence cross-functional engineering teams. * Excellent written and verbal communication skills in English Nice to have * Experience with MLOps, computer vision, foundation models, or large language models. * Knowledge of AI performance, bias, explainability, model drift, human oversight, and AI governance. * Experience with Azure or AWS, Kubernetes, containerized applications, DevSecOps, and continuous software delivery. * Knowledge of connected-device interoperability, including DICOM, HL7, and FHIR. * Familiarity with FDA Good Machine Learning Practice and ISO/IEC 42001. ## Description As Senior Risk Manager within the Azurion Eye program, you own and continuously evolve the product risk management strategy across the complete product lifecycle. You ensure that AI-enabled, cloud-based, and connected medical solutions are developed and maintained in line with applicable safety, quality, and regulatory requirements. Your role: * Lead product risk management activities from early concept and architecture through development, regulatory submission, post-market surveillance, and continuous software releases. * Develop and maintain the Product Risk Management File in accordance with ISO 14971 and Philips QMS requirements. * Lead hazard analyses, benefit-risk assessments, software risk analyses, and AI risk assessments. * Define safety strategies for AI-enabled SaMD, SaNMD, cloud-native software, connected medical devices, and distributed services. * Facilitate cross-functional risk workshops with Engineering, Clinical, Quality, Regulatory Affairs, and Product Management. * Integrate risk management into Agile, DevSecOps, CI/CD, and software lifecycle practices. * Use complaint data, software telemetry, clinical feedback, and AI performance monitoring to support product safety decisions. * Support regulatory submissions, audits, CAPA investigations, field actions, and post-market surveillance. * Coach development teams and promote a strong product safety culture. ## Related Videos - [ZEISS & Microsoft - Building the Next Generation Medical Ecosystem in the Cloud](https://www.wearedevelopers.com/videos/424-zeiss-microsoft-building-the-next-generation-medical-ecosystem-in-the-cloud) - [Understanding Kubernetes in a visual way](https://www.wearedevelopers.com/videos/100085-understanding-kubernetes-in-a-visual-way) - [DevSecOps: Injecting Security into Mobile CI/CD Pipelines](https://www.wearedevelopers.com/videos/273-devsecops-injecting-security-into-mobile-ci-cd-pipelines) - [Instant KAI Sandboxes with vCluster: Multi-Tenant, Multi-Scheduler GPU Sharing](https://www.wearedevelopers.com/videos/100333-instant-kai-sandboxes-with-vcluster-multi-tenant-multi-scheduler-gpu-sharing) - [AI in High-Stakes Industries: Lessons Learned](https://www.wearedevelopers.com/videos/100253-ai-in-high-stakes-industries-lessons-learned) - [DevSecOps: Security in DevOps](https://www.wearedevelopers.com/videos/36-devsecops-security-in-devops) ## Related Articles - [Navigating the AI Shift](https://www.wearedevelopers.com/magazine/629-navigating-the-ai-shift) - [Coffee with Developers - Maria Apazoglou - Making AI understandable for all in production](https://www.wearedevelopers.com/magazine/475-coffee-with-developers-maria-apazoglou-making-ai-understandable-for-all-in-production) - [The Biggest German Tech Companies](https://www.wearedevelopers.com/magazine/424-the-biggest-german-tech-companies) - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [Best Companies in the Netherlands: Top 25 Companies in 2023 ](https://www.wearedevelopers.com/magazine/193-best-companies-in-the-netherlands-top-25-companies-in-2023) - [MLOps – What’s the deal behind it?](https://www.wearedevelopers.com/magazine/125-mlops-what-s-the-deal-behind-it)