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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.

• 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.

• Doing meaningful work should come with fair, transparent rewards.
• The base salary range for this role is €78187-€130312.
• We determine pay within the range using objective factors, like the skills the role requires, your relevant experience and the responsibility you'll have in this role, alongside internal equity and local market considerations.
• This role is eligible for 3% bonus, with your rewards linked to KPIs/company results.
• We'll share the full approach with you during the interview process, so you can make a clear, informed decision.

We believe that we are better together than apart. For our office-based teams, this means working in‑person at least 3 days per week.

Are you ready to do the work of your life to help the lives of others? Learn more about our business, discover our rich and exciting history and learn more about our purpose. Learn more about our culture of impact with care.

At Philips, we believe that every human matters. As a global health‑tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people’s lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success.

It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism. To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace.

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