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 

Maximum Salary: $ 188300 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles 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).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. 

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.  The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.