You will work at the intersection of technology, design control, and regulation, ensuring that product and system maturity matches Ambu's quality and patient safety ambitions. You will combine deep technical understanding with a strong design control discipline, acting as the technical anchor between AI/ML developers, system engineers, quality, regulatory affairs, and project management. * Establishing and maintaining technical and documentation overview across system interfaces, software components, data pipelines, and model lifecycle aspects. * Driving lifecycle management activities, including design changes, product updates, NCRs, and CAPAs for marketed systems. * Strong hands-on experience with design control, requirements management, risk management, and traceability.
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