Systems Engineer

Purpose

This role is part of AbbVies 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: Bachelors 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:  < 5%. 

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 locationand 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 Companys soleand absolute discretion unless and until paid and may be modified at the Companys 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. 

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Work :

No

Employment Type :

Full-time