Systems Engineer

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Purpose

This 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 readiness

Duties & Responsibilities

• DHF 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.