Systems Engineer
AbbVie
5 months ago
Remote friendly (North Chicago, IL)
United States
IT
Purpose:
- Responsible for the accurate and compliant management of Design History Files (DHFs) for medical devices and/or combination products throughout their lifecycle within systems engineering.
- Ensures DHF documentation adheres to regulatory standards (e.g., FDA 21 CFR 820.30, ISO 13485, ISO 14971) and company procedures to support product development, design changes, regulatory submissions, and audit readiness.
- Lead Aesthetics New Product Introductions (design inputs, traceability, risk management and validation).
Responsibilities:
- DHF Management (Marketed Product Support - MPS):
- Maintain DHFs for on-market products (Design Inputs, Design Validation, Trace Matrix).
- Ensure complete and accurate traceability across design plans, inputs/outputs, verification/validation records, risk management files, and design change documentation.
- Collaborate with cross-functional teams to gather, impact assess, and incorporate changes into the DHF.
- Aesthetics New Product Introduction (NPI):
- Participate in full V-model development up to design transfer (including architecture).
- Support system and user risk assessment/management.
- Coordinate cross-functional integration of drug product development and third-party development.
- Regulatory Compliance:
- Support regulatory submissions via well-maintained, audit-ready DHFs; ensure conformance to consensus standards and timely closure of assigned change plan action items.
- May support regulatory inspections/audits by providing DHF documentation.
- Identify and address DHF gaps/discrepancies.
- Process Improvement:
- Recommend improvements to DHF documentation processes/procedures.
- May participate in DHF remediation activities.
Preferred Qualifications:
- 5+ years in medical device and/or pharmaceutical industry focused on Design Controls and marketed product support DHF change control.
- Ability to multitask and meet timelines.
- Experience with TrackWise and Polarion.
- Technical writing skills and strong verbal communication.
Technical Skills:
- Proficiency in DHF creation, maintenance, organization, and impact assessment.
- Experience with risk management, requirement definition, traceability, change management, and Design Validation.
- DMS/eQMS experience preferred.
- Experience working in regulated environments compliant to ISO 13485 and 21 CFR 820 and MDR; familiarity with ISO 14971, ISO 11608, ISO 11040.
- Experience with injection-based systems (e.g., pre-filled syringes, on-body delivery systems).
Soft Skills:
- Strong organizational skills and attention to detail.
- Independent and collaborative work in cross-functional teams.
- Problem-solving and analytical skills.
- Proactive consultation for quality judgment.
Physical/Work Requirements:
- Office environment with hybrid schedule; ~95% computer-based work (reading/writing).
Qualifications:
- BS or equivalent with typically 7+ years experience, or MS or equivalent with typically 5+ years experience.
- Ability to independently design, execute, and interpret critical experiments.
- Ability to learn and master new experimental techniques.
- Ability to multitask and meet timelines.
- Scientific writing and verbal communication skills.
Benefits (if applicable in job description):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Short-term incentive program eligible.
Application instructions:
- Not provided in the job description text.
- Responsible for the accurate and compliant management of Design History Files (DHFs) for medical devices and/or combination products throughout their lifecycle within systems engineering.
- Ensures DHF documentation adheres to regulatory standards (e.g., FDA 21 CFR 820.30, ISO 13485, ISO 14971) and company procedures to support product development, design changes, regulatory submissions, and audit readiness.
- Lead Aesthetics New Product Introductions (design inputs, traceability, risk management and validation).
Responsibilities:
- DHF Management (Marketed Product Support - MPS):
- Maintain DHFs for on-market products (Design Inputs, Design Validation, Trace Matrix).
- Ensure complete and accurate traceability across design plans, inputs/outputs, verification/validation records, risk management files, and design change documentation.
- Collaborate with cross-functional teams to gather, impact assess, and incorporate changes into the DHF.
- Aesthetics New Product Introduction (NPI):
- Participate in full V-model development up to design transfer (including architecture).
- Support system and user risk assessment/management.
- Coordinate cross-functional integration of drug product development and third-party development.
- Regulatory Compliance:
- Support regulatory submissions via well-maintained, audit-ready DHFs; ensure conformance to consensus standards and timely closure of assigned change plan action items.
- May support regulatory inspections/audits by providing DHF documentation.
- Identify and address DHF gaps/discrepancies.
- Process Improvement:
- Recommend improvements to DHF documentation processes/procedures.
- May participate in DHF remediation activities.
Preferred Qualifications:
- 5+ years in medical device and/or pharmaceutical industry focused on Design Controls and marketed product support DHF change control.
- Ability to multitask and meet timelines.
- Experience with TrackWise and Polarion.
- Technical writing skills and strong verbal communication.
Technical Skills:
- Proficiency in DHF creation, maintenance, organization, and impact assessment.
- Experience with risk management, requirement definition, traceability, change management, and Design Validation.
- DMS/eQMS experience preferred.
- Experience working in regulated environments compliant to ISO 13485 and 21 CFR 820 and MDR; familiarity with ISO 14971, ISO 11608, ISO 11040.
- Experience with injection-based systems (e.g., pre-filled syringes, on-body delivery systems).
Soft Skills:
- Strong organizational skills and attention to detail.
- Independent and collaborative work in cross-functional teams.
- Problem-solving and analytical skills.
- Proactive consultation for quality judgment.
Physical/Work Requirements:
- Office environment with hybrid schedule; ~95% computer-based work (reading/writing).
Qualifications:
- BS or equivalent with typically 7+ years experience, or MS or equivalent with typically 5+ years experience.
- Ability to independently design, execute, and interpret critical experiments.
- Ability to learn and master new experimental techniques.
- Ability to multitask and meet timelines.
- Scientific writing and verbal communication skills.
Benefits (if applicable in job description):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Short-term incentive program eligible.
Application instructions:
- Not provided in the job description text.