Software and AI Product Evaluator
hace 1 semana
We are SGS, the world's leading testing, inspection, and certification company. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer, and more interconnected world. A Software & Artificial Intelligence (AI) Product Assessor role at SGS will allow you to make a significant impact in the field of certification.
Key Responsibilities:
- Conduct thorough technical documentation reviews of Software as a Medical Device (SaMD) and devices using AI/Machine Learning (ML) and ensure compliance with EU regulations and standards.
- Collaborate with cross-functional teams to increase efficiency and quality.
- Develop training and present it to others in SGS or externally as deemed necessary.
- Project manage reviews as appropriate, to maximize efficiencies, enhance client satisfaction, and ensure compliance with standards.
- Support/assist on queries raised from the review.
- Work at all times to adhere to KPIs set as an individual and within a team.
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).
Estimated Salary Range: $90,000 - $120,000 per year
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