Principal AI Technical Lead

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.           

About the role:

Boston Scientific ranked #2 among medical device companies on Forbes America's Best Places to Work for Engineers 2026. Whether your passion lies in systems, software, human factors, or beyond, this is a place where you can grow your career and be part of something bigger—advancing science for life.

 

As a Principal AI Technical Lead in the Endoscopy division, you will lead the design, development, and lifecycle management of AI-based Software as a Medical Device (SaMD). In this pivotal role, you will ensure regulatory compliance, technical excellence, and innovation in AI applications that improve patient outcomes. You will also serve as a subject matter expert and mentor, influencing cross-functional teams and driving Boston Scientific’s leadership in AI-enabled medical devices.

 

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

 

Your responsibilities will include:

• 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.

 

Required qualifications:

• 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 qualifications:

• 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

 

 

Requisition ID: 619526 

Minimum Salary: $ 99100