Business Analyst: AI Validation

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 the company Quality System requirements.

Locations: Boston, MA or Minneapolis/St. Paul, MN

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 to 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 the company 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:

• Minimum of 5 years of 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.