Systems Engineer

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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 (https://www.tiktok.com/@abbvie) .

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

Qualifications

• Education: Bachelor's degree in engineering, physical sciences, or a related field.
• Experience: 2 years of experience in the medical device or pharmaceutical industry, with a focus on Design Controls including marketed product support DHF change control.
• Technical Skills:
• Basic understanding of medical device or combination product development processes and change control.
• Proficiency in Design History File creation, maintenance, and organization.
• Proficiency in DHF impact assessment.
• Familiarity with regulatory requirements and standards (e.g., FDA 21 CFR 820.30, ISO 13485, ISO 14971)
• Experience with risk management activities, requirement definition, Design Verification, and Design Validation processes.
• Experience with Document Management Systems (DMS) or Electronic Quality Management Systems (eQMS) is preferred.
  
  

Preferred Qualifications

• Experience with TrackWise, Polarion
  
  

Physical Job Requirements

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

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ?

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time ofthis posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future. ?
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.?
• This job is eligible to participate in our short-term incentive programs. ?
• This job is eligible to participate in our long-term incentive programs?
  
  

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of anybonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's soleand absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.? Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Salary: $73,000 - $138,500

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