Strong hands-on experience with design control, requirements management, risk management, and traceability. 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. Two days will rarely look the same, but your work will consistently focus on driving technical clarity, risk awareness, and release readiness of complex AI-enabled systems. * 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. ...
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