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Boston Scientific · 8 hours ago

Principal AI Technical Lead

Arden Hills, MN

Full-time

Hybrid

Senior Level, Lead/Staff

$99K/yr - $188K/yr

10+ years exp

Boston Scientific is a leader in medical science committed to advancing health solutions. As a Principal AI Technical Lead in the Endoscopy division, you will lead the design and development of AI-based Software as a Medical Device (SaMD), ensuring compliance with regulatory standards and driving innovation 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

AI-based SaMD systemsFDA regulatory complianceGMLP guidelinesProduct lifecycle managementAI/ML algorithmsCybersecurity for medical devicesRisk management strategiesData governance practicesCross-functional collaborationMentorship

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 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

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