PurposeThis role is part of AbbVie’s Product Development, Science & Technology Systems Engineering team located in Lake County, IL.Responsible for the accurate and compliant management of Design History Files (DHFs) for medical devices or combination products throughout their lifecycle within the scope of systems engineering. This role ensures that all DHF documentation adheres to regulatory standards (e.g., FDA 21 CFR 820.30, ISO 13485, ISO 14971) and company procedures, supporting product development, design changes, regulatory submissions, and audit readinessDuties & ResponsibilitiesDHF Management:Supports the maintenance of Design History Files (DHFs) for on-market products. (Design Inputs, Design Validation, Trace Matrix)Ensures complete and accurate traceability of DHF documentation, including design plans, inputs, outputs, verification and validation records, risk management files, and design change documentation.Collaborates with cross-functional teams to gather, impact assess and incorporate necessary changes into the DHF.Regulatory Compliance:Supports regulatory submissions by ensuring well-maintained and audit-ready DHFs, including ensuring conformance to the latest recognized consensus standards and timely closure of assigned change plan action items.May participate in regulatory inspections and audits, providing DHF documentation as requested.Documentation and Review:Identify and address any gaps or discrepancies within the DHF.Supports the creation and maintenance of traceability matrices, ensuring links between design elements are clearly documented.Process Improvement:Identifies and recommends improvements to DHF documentation processes and procedures.May participate in DHF remediation activities.