Purpose:

This role is part of AbbVie’s Product Development, Science & Technology (PDS&T) Systems Engineering team located in Lake County, IL.

Responsible for the accurate and compliant management of Design History Files (DHFs) for medical devices and/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.  In addition, you will lead Aesthetics New Product Introductions (design inputs, traceability, risk management and validation). 

Responsibilities:

DHF Management:

Marketed Product Support (MPS):

• 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.

Aesthetics New Product Introduction (NPI):

• Engaging in full v-model development leading up to design transfer including architecture.
• Supports risk assessment and management activities (system and user).
• Works with cross-functional teams on integration of drug product development and third-party development activities.

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.

Process Improvement:

• Identifies and recommends improvements to DHF documentation processes and procedures.
• May participate in DHF remediation activities.

Preferred Qualifications:

• Experience: 5+ years of experience in the medical device and/or pharmaceutical industry, with a focus on Design Controls including marketed product support DHF change control.
• Ability to multitask and work within timelines
• Experience with TrackWise, Polarion
• Demonstrated technical writing skills and strong verbal communication skills.

Technical Skills:

• Proficiency in Design History File creation, maintenance, and organization along with impact assessment.
• Experience with risk management activities, requirement definition, , traceability, change management and Design Validation processes.
• Experience with Document Management Systems (DMS) or Electronic Quality Management Systems (eQMS) is preferred.
• Experience in design and development processes that conform to standards including ISO 14971, ISO 11608, ISO 11040 and the ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820 and MDR.
• Experience working on injection-based systems such as pre-filled syringes or on-body delivery systems. 

Soft Skills:

• Strong organizational skills and attention to detail.
• Ability to work independently and collaboratively within cross-functional teams.
• Problem-solving and analytical skills.
• High awareness of personal limits and a willingness to proactively consult others to ensure quality judgment.

Physical Job Requirements:

• This position is in an office environment with a hybrid schedule.  Work primarily entails working at a computer, reading and/or writing (~95%).  Travel Time: < 5%.