Business Analyst: AI Validation

Additional Location(s):US-MA-Marlborough; US-MN-Arden Hills

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:

This is a hands-on validation execution role focused on documentation, testing, and compliance alignment for AI-enabled Quality and Regulatory tools. The position supports validation activities by preparing documentation, executing testing, managing traceability and change control, and coordinating cross-functional inputs to ensure alignment with applicable software lifecycles and Boston Scientific Quality System requirements.

Work model, sponsorship, relocation:

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:

• Draft validation documentation such as Intended Use statements, GSMA content, test plans, and test scripts based on governance guidance and lifecycle expectations.
• Execute validation testing according to the applicable lifecycle (e.g., Gen AI lifecycle, GSM), including evidence capture, defect logging, and result documentation.
• Maintain complete traceability across requirements, intended use, test cases, and outputs.
• Support preparation and routing of change-control documentation associated with validation deliverables.
• Collaborate with Quality and Regulatory process owners, SMEs, and end users to understand workflow needs and translate them into testable requirements.
• Incorporate user feedback into validation documentation and testing refinements.
• Identify ambiguities or gaps in requirements and escalate to governance leads for clarification.
• Coordinate validation readiness activities such as access, test data preparation, environment setup, and scheduling.
• Work closely with Quality Systems stakeholders, Data Scientists, Developers, Legal representatives, and Quality/Regulatory SMEs to ensure validation coverage and timely execution.
• Participate in cross-functional discussions to clarify requirements, test expectations, and validation outcomes.
• Ensure all validation activities are compliant with Boston Scientific software lifecycles, documentation standards, and applicable regulatory expectations.
• Support audit readiness by maintaining accurate, complete, and defensible validation packages.
• Identify opportunities to improve validation templates, documentation clarity, and lifecycle execution, and share input with governance leads.
• Assist in developing standardized test cases and documentation patterns to improve efficiency and consistency across AI validation projects.
• Organize and track validation activities to support timely delivery of milestones.
• Manage concurrent validation tasks across multiple AI tools, providing updates to project managers as needed.

Qualifications:

Required qualifications:

• Minimum of 5 years' experience in software validation, quality engineering, or validation roles in a regulated environment (medical device, pharma, biotech, or equivalent).
• Strong knowledge of validation documentation practices including requirements traceability, intended use, test case development, and change control.
• Demonstrated experience executing validation testing and preparing audit-ready documentation.
• Ability to interpret user workflows and translate them into testable requirements.
• Excellent documentation skills with strong attention to detail and compliance focus.
• Ability to collaborate effectively with Data Scientists, developers, Quality/Regulatory SMEs, and process owners.
• Strong analytical and problem-solving skills with the ability to identify and escalate documentation or testing gaps.
• Comfortable managing multiple validation tasks in parallel projects.
• Experience following structured validation lifecycles, SOPs, and WI-driven processes.
• Strong communication skills with the ability to explain test outcomes and documentation gaps clearly and concisely.
• Ability to work independently within defined governance and validation frameworks.

Preferred qualifications:

• Familiarity with AI/ML-enabled tools, automated systems, or algorithmic platforms (training can be provided).
• Experience with Gen AI lifecycle, GSM, or similar validation models.
• Understanding of Quality and Regulatory workflows in the medical device or life sciences industry.

Requisition ID:623497

Minimum Salary: $85000

Maximum Salary: $161500

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.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life byprovidinga broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological,neurologicaland urological diseases and conditions. Learn more atwww.bostonscientific.comand follow us onLinkedIn.

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.