Systems Engineer

AbbVie-posted 3 months ago

Full-time • Entry Level

North Chicago, IL

Chemical Manufacturing

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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 (DHF) 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.

Supports the maintenance of Design History Files (DHF) for on-market products.
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.
Supports regulatory submissions by ensuring well-maintained and audit-ready DHFs.
May participate in regulatory inspections and audits, providing DHF documentation as requested.
Identifies and addresses any gaps or discrepancies within the DHF.
Supports the creation and maintenance of traceability matrices, ensuring links between design elements are clearly documented.
Identifies and recommends improvements to DHF documentation processes and procedures.
May participate in DHF remediation activities.

A Bachelor's Degree in Engineering, science or closely related discipline is desired, or equivalent technical experience plus demonstrated competence.
Desired 2+ years of significant engineering and/or operational experience.
Has demonstrated competency within a discipline.
Possesses a working technical knowledge and application of concepts, practices, and procedures.
Ability to work on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.
Demonstrates judgment within defined procedures and practices to determine appropriate action.
Interacts well with diverse groups within engineering and maintains strong working relationships with internal and external collaborators.
Possesses interpersonal skills to negotiate and reconcile differences.
Has a technical background in health care, medical devices, pharmaceutical, biologics, or similar industries (preferred).

Experience with TrackWise.
Experience with Polarion.

Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k) to eligible employees
Short-term incentive programs
Long-term incentive programs

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