Business Analyst: AI Validation

<p><strong><span>About the role:</span></strong></p> <p>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.</p> <p><strong>Locations: Boston, MA or Minneapolis/St. Paul, MN</strong></p> <p><strong><span>Responsibilities will include:</span></strong></p> <ul> <li>Draft validation documentation such as Intended Use statements, GSMA content, test plans, and test scripts based on governance guidance and lifecycle expectations.</li> <li>Execute validation testing according to the applicable lifecycle (e.g., Gen AI lifecycle, GSM), including evidence capture, defect logging, and result documentation.</li> <li>Maintain complete traceability across requirements, intended use, test cases, and outputs.</li> <li>Support preparation and routing of change-control documentation associated with validation deliverables.</li> <li>Collaborate with Quality and Regulatory process owners, SMEs, and end users to understand workflow needs and translate them into testable requirements.</li> <li>Incorporate user feedback into validation documentation and testing refinements.</li> <li>Identify ambiguities or gaps in requirements and escalate to governance leads to clarification.</li> <li>Coordinate validation readiness activities such as access, test data preparation, environment setup, and scheduling.</li> <li>Work closely with Quality Systems stakeholders, Data Scientists, Developers, Legal representatives, and Quality/Regulatory SMEs to ensure validation coverage and timely execution.</li> <li>Participate in cross-functional discussions to clarify requirements, test expectations, and validation outcomes.</li> <li>Ensure all validation activities are compliant with the company software lifecycles, documentation standards, and applicable regulatory expectations.</li> <li>Support audit readiness by maintaining accurate, complete, and defensible validation packages.</li> <li>Identify opportunities to improve validation templates, documentation clarity, and lifecycle execution, and share input with governance leads.</li> <li>Assist in developing standardized test cases and documentation patterns to improve efficiency and consistency across AI validation projects.</li> <li>Organize and track validation activities to support timely delivery of milestones.</li> <li>Manage concurrent validation tasks across multiple AI tools, providing updates to project managers as needed.</li> </ul> <p><strong>&nbsp;</strong></p> <p><strong><span>Qualifications:</span></strong></p> <p><strong>Required:</strong></p> <ul> <li>Minimum of 5 years of experience in software validation, quality engineering, or validation roles in a regulated environment (medical device, pharma, biotech, or equivalent).</li> <li>Strong knowledge of validation documentation practices including requirements traceability, intended use, test case development, and change control.</li> <li>Demonstrated experience executing validation testing and preparing audit-ready documentation.</li> <li>Ability to interpret user workflows and translate them into testable requirements.</li> <li>Excellent documentation skills with strong attention to detail and compliance focus.</li> <li>Ability to collaborate effectively with Data Scientists, developers, Quality/Regulatory SMEs, and process owners.</li> <li>Strong analytical and problem-solving skills with the ability to identify and escalate documentation or testing gaps.</li> <li>Comfortable managing multiple validation tasks in parallel projects.</li> <li>Experience following structured validation lifecycles, SOPs, and WI-driven processes.</li> <li>Strong communication skills with the ability to explain test outcomes and documentation gaps clearly and concisely.</li> <li>Ability to work independently within defined governance and validation frameworks.</li> </ul> <p><strong>Preferred:</strong></p> <ul> <li>Familiarity with AI/ML-enabled tools, automated systems, or algorithmic platforms (training can be provided).</li> <li>Experience with Gen AI lifecycle, GSM, or similar validation models.</li> <li>Understanding of Quality and Regulatory workflows in the medical device or life sciences industry.</li> </ul> <p><strong>&nbsp;</strong></p>