Boston Scientific · 8 hours ago
Business Analyst: AI Validation
US-MN-Arden Hills
Full-time
Hybrid
Senior Level
5+ years expBoston Scientific is a leader in medical science dedicated to solving important health industry challenges. They are seeking a Business Analyst focused on AI validation, responsible for executing validation activities, preparing documentation, and ensuring compliance with quality systems and regulatory requirements.
Health CareMedicalMedical Device
No H1B
Responsibilities
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
Qualification
Required
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
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
Benefits
Variable compensation governed by the Sales Incentive Compensation Plan
Core and optional benefits offered at BSC
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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