Principal AI Technical Lead role at Boston Scientific, leading design, development, and lifecycle management of AI-based Software as a Medical Device (SaMD) in the Endoscopy division.
Requirements
- Bachelor's or Master's degree in Computer Science, Biomedical Engineering, or a related field.
- Minimum of 10 years' experience designing, developing and productizing AI-based SaMD systems.
- Proven track record of managing the full product lifecycle for AI SaMD under FDA and EU regulatory frameworks.
- Hands-on experience with CADe and CADx development and submissions to U.S. FDA and EU notified bodies.
- Deep understanding of GMLP, FDA guidelines and EU MDR requirements for AI SaMD.
- Familiarity with IMDRF SaMD framework or other SaMD product development life cycle processes.
- Knowledge of key data governance practices in AI SaMD development.
- Strong expertise in AI/ML algorithms, validation, and performance monitoring in regulated environments.
- Experience in cybersecurity for AI medical devices, including risk assessment and mitigation strategies.
Benefits
- Variable compensation
- Annual bonus target
- Long-term incentives
- Core and optional employee benefits
