Software and Artificial Intelligence Product Assessor

hace 7 días

Madrid, Madrid, España Sgs A tiempo completo

Company Overview

SGS is the world's leading testing, inspection, and certification company, recognized as the global benchmark for sustainability, quality, and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer, and more interconnected world.

Job Summary

We are seeking a highly skilled Software and Artificial Intelligence Product Assessor to join our dynamic team at SGS. As a key member of our team, you will be responsible for conducting thorough technical documentation reviews of Software as a Medical Device (SaMD) and devices using Artificial Intelligence (AI) and Machine Learning (ML), ensuring compliance with EU regulations and standards.

Key Responsibilities

Conduct technical documentation reviews of SaMD and devices using AI/ML, ensuring compliance with EU regulations and standards

Collaborate with cross-functional teams to increase efficiency and quality

Develop and present training to others in SGS or externally as deemed necessary

Project manage reviews to maximize efficiencies, enhance client satisfaction, and ensure compliance with standards

Support/assist on queries raised from the review

Maintain personal competency to review technical files and technical documentation

Provide the highest level of service throughout the SGS network, offering medical devices certification and stakeholders through efficient service delivery

Requirements

Bachelor's degree in a related discipline (e.g., engineering, or other relevant sciences)

Four years of professional experience in the field of healthcare products or related activities, such as design, manufacturing, auditing, or research, of which two years shall be in developing SaMD demonstrating knowledge of one or more programming languages (preferable in MDSW or other critical software requiring compliance with regulations) and AI/ML models in specific industry/academic research

Thorough knowledge and understanding of the Software Life Cycle processes: requirement analysis, design and coding, configuration management including version and change control, testing including unit, integration, regression and system testing, validation and release, and problem resolution techniques including debugging techniques, root cause analysis and code reviews

Knowledge and understanding of the related standards: IEC 62304, IEC 82304, IEC 81001-5-1, IEC 62366, etc.

Thorough knowledge and understanding of AI regulations, released standards/guidance and AI/ML tools/libraries

Good written English skills (as reports will be reviewed/queried in English)

Knowledge of the following Technical File codes desirable (COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017) MDS1009 and MDS0315

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