✦ Luna Orbit — Healthcare & Medical

Business Analyst: AI Validation

at Boston Scientific

📍 Arden Hills, MN, US, 55112 Hybrid Posted March 13, 2026
Type Not Specified
Experience mid
Exp. Years Not specified
Education Not specified
Category Healthcare & Medical

This role involves executing validation activities, preparing documentation, and ensuring compliance for AI-enabled medical device tools in a hybrid work setting.

  • Draft validation documentation
  • Execute validation testing
  • Maintain traceability
  • Support audit readiness
  • Coordinate validation activities

Hands-on validation execution, documentation management, compliance with software lifecycle and regulatory standards, cross-functional collaboration.

The ideal candidate is a mid-level quality assurance professional with experience in validation, documentation, and regulatory compliance within medical device or healthcare industries. They should have hands-on experience executing validation activities and preparing validation documentation for AI-enabled tools.

Validation documentationTestingRegulatory complianceValidation activitiesDocumentation
Software lifecycle knowledgeQuality System standardsCross-functional collaboration
GSMValidation toolsChange control systems
Validation documentationTestingTraceabilityChange controlSoftware lifecycleRegulatory complianceValidation testingDocumentation standards
Validation documentationTestingTraceabilityChange controlSoftware lifecycleRegulatory complianceValidation testingDocumentation standards
CollaborationCommunicationProblem-solvingAttention to detailTeamwork
Industry Healthcare & Medical
Job Function Validation execution and documentation for AI-enabled medical device tools
Validation documentationTestingTraceabilityChange controlSoftware lifecycleRegulatory complianceValidation testingDocumentation standardsAI-enabled QualityRegulatory toolsValidation activitiesValidation packagesAudit readinessDocumentationCross-functional collaboration

Lack of experience in validation or regulatory documentation, No healthcare or medical device background, Inability to work in a hybrid work environment

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