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. * 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. 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. In this role, you will be involved in all phases of the product lifecycle – from early concept and architectural decisions through development, verification, regulatory submission, market release, and sustained lifecycle management.
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