Quality Engineer for AI and ML Solutions
Há 6 dias
About Sword Health
Sword Health is a pioneering company that aims to revolutionize the way we approach pain management. Our end-to-end platform uses artificial intelligence and machine learning to predict, prevent, and treat pain, making it a game-changer in the healthcare industry.
As a Senior Quality Engineer for AI/ML, you will be part of a dynamic team responsible for developing and maintaining AI/ML-enabled SaMD. Your primary role will involve guiding AI/ML development teams on quality processes, conducting reviews of engineering activities, and overseeing model retraining and updates.
Key Responsibilities
- Develop and implement the quality management system for AI/ML-enabled SaMD, ensuring compliance with internal QMS procedures and external regulations (FDA, EU AI Act, Health Canada, etc.)
- Interpret and implement relevant regulatory guidance to ensure AI/ML software meets all applicable requirements for safety, performance, and cybersecurity
- Conduct AI-specific risk assessments, including bias, algorithmic drift, and security vulnerabilities, in accordance with BS/AAMI 34971 and ISO 14971
- Coordinate AI/ML software verification and validation activities
Requirements
- Bachelor's degree in Computer Science, Engineering, or a related field
- 4+ years of experience in Quality Software Engineering or a related role within the medical device industry
- Proven experience with AI/ML-enabled SaMD development and quality assurance
- Strong understanding of AI/ML lifecycle processes, including data management, algorithm training, model validation, CI/CD pipeline, DevOps for automated testing, and Predetermined Change Control Plan (PCCP)
Benefits
- A dynamic, innovative work environment with opportunities for growth and professional development
- A chance to work on cutting-edge technology and contribute to shaping the future of healthcare
- Career advancement and salary competitiveness
- Flexible remote work options and unlimited vacation time
- Comprehensive benefits package, including access to digital therapist sessions
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