Boston Scientific · 1 day ago
Principal AI Technical Lead
Arden Hills, MN
Full-time
Hybrid
Senior Level, Lead/Staff
$99K/yr - $188K/yr
10+ years expBoston Scientific is a leading company in the medical device industry, renowned for its commitment to innovation and quality. The Principal AI Technical Lead will be responsible for leading the design, development, and lifecycle management of AI-based Software as a Medical Device, ensuring compliance with regulatory standards and driving innovation in AI applications to improve patient outcomes.
Health CareMedicalMedical Device
No H1B
Responsibilities
Lead the design and development of AI-based SaMD systems, ensuring compliance with FDA and EU notified body regulations
Drive the end-to-end product lifecycle for AI SaMD—from concept through post-market surveillance—following regulatory guidelines and best practices
Support regulatory submissions for CADe and CADx devices to U.S. FDA and EU notified bodies, ensuring timely and successful approvals
Implement and maintain Good Machine Learning Practices (GMLP) and other FDA guidelines for AI SaMD development, validation, and continuous learning systems
Ensure adherence to Product Lifecycle Process (PLCP) or equivalent frameworks for AI SaMD, aligned with industry standards for design controls, risk management, and documentation
Establish and enforce cybersecurity frameworks for AI SaMD devices, addressing data integrity, privacy, and resilience against threats
Collaborate with R&D, Quality, Clinical, and Regulatory teams to ensure robust design controls and risk management throughout development
Provide technical leadership and mentorship to engineering teams, promoting innovation and compliance with quality and regulatory standards
Monitor and interpret emerging regulations, standards, and technologies to ensure Boston Scientific remains at the forefront of AI SaMD compliance and innovation
Qualification
Required
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 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 including risk assessment and mitigation strategies (preferrably for AI medical devices)
Preferred
PhD in Computer Science, Biomedical Engineering, or related field
Proven leadership ability with cross-functional collaboration and regulatory engagement experience
Experience with regulated software/medical device standards, such as: – IEC 62304 (Software Life Cycle) – ISO 13485 (Quality Systems) – IEC 14971 (Risk Management) – IEC 27001 (Information Security) – HIPAA/PHI data handling protocols
Benefits
Compensation may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$10.02B2025-02-21Post Ipo Debt· $1.58B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
2026-01-24
2026-01-23
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