Business Analyst: AI Validation

bostonscientific•Marlborough, MN

23h•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

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.

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.