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. 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. * Ensuring compliance with relevant standards and regulations, such as IEC 62304, SaMD, ISO 14971, MDR / FDA requirements, and emerging AI-related guidance and standards (e.g. AI/ML lifecycle management, data 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.
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