About this role
This role is part of AbbVie’s PDS&T Systems Engineering team and owns compliant Design History File (DHF) management for medical devices and/or combination products. You will ensure DHF documentation supports regulatory submissions and audit readiness while leading Aesthetics New Product Introductions.
Key Responsibilities
- Maintain and support DHFs for on-market products including traceability and change control
- Lead Aesthetics NPI activities including v-model development, risk assessment, and design transfer
- Ensure DHF documentation is conformed to regulatory standards and company procedures
- Support regulatory submissions and audits by providing audit-ready DHFs and closing action items
- Identify gaps in DHF documentation and recommend process improvements
Technical Overview
You will manage DHFs end-to-end with complete traceability across design inputs, outputs, verification/validation, risk management files, and change documentation. The role emphasizes compliance to FDA 21 CFR 820.30, ISO 13485, and ISO 14971, including risk assessment and v-model development leading to design transfer.
Ideal Candidate
The ideal candidate is a mid-level systems engineer with 5+ years in the medical device and/or pharmaceutical industry, focused on Design Controls and Design History File (DHF) change control. They have strong technical writing and communication skills, can maintain DHFs with complete traceability, and understand risk management and regulatory requirements (FDA 21 CFR 820.30, ISO 13485, ISO 14971).
Must-Have Skills
Design ControlsDesign History Files (DHFs)traceabilityimpact assessmentrisk assessment and managementDesign Validationchange managementregulatory standards conformance (FDA 21 CFR 820.30ISO 13485ISO 14971)technical writing skillsverbal communication skills
Nice-to-Have Skills
TrackWisePolarionDocument Management Systems (DMS)Electronic Quality Management Systems (eQMS)
Tools & Platforms
TrackWisePolarionDocument Management Systems (DMS)Electronic Quality Management Systems (eQMS)
Required Skills
Design History File (DHF) creationDesign History File (DHF) maintenanceDesign History File (DHF) organizationimpact assessmenttraceabilitytrace matrixdesign inputsdesign outputsverification and validation recordsrisk management filesdesign change documentationDesign ControlsDesign Validation processeschange managementDesign History File (DHF) change controlrisk assessment and managementv-model developmentdesign transferarchitectureregulatory submissions supportaudit readinessregulatory inspections and auditsdocumentation and review
Hard Skills
Design History File (DHF) creationDesign History File (DHF) maintenanceDesign History File (DHF) organizationimpact assessmenttraceabilitytrace matrixdesign inputsdesign outputsverification and validation recordsrisk management filesdesign change documentationDesign ControlsDesign Validation processeschange managementDesign History File (DHF) change controlrisk assessment and managementrisk management (system and user)v-model developmentdesign transferarchitectureregulatory submissions supportaudit readinessregulatory inspections and auditsdocumentation and review (gap/discrepancy identification)Document Management Systems (DMS)Electronic Quality Management Systems (eQMS)FDA 21 CFR 820.30ISO 13485ISO 14971
Soft Skills
multitaskwork within timelinestechnical writing skillsstrong verbal communication skillscross-functional collaborationcollaboration with cross-functional teamsattention to detail
Keywords for Your Resume
Systems EngineerDesign History FileDesign History Files (DHFs)DHFDesign ControlsDesign InputsDesign OutputsDesign ValidationTrace Matrixtraceabilityimpact assessmentdesign change documentationchange managementrisk managementrisk assessment and managementv-model developmentdesign transferarchitectureFDA 21 CFR 820.30ISO 13485ISO 14971audit readinessTrackWisePolarionDocument Management Systems (DMS)Electronic Quality Management Systems (eQMS)
Deal Breakers
Must have experience with Design Controls and DHF management (5+ years preferred by posting), Must be able to demonstrate work aligned to FDA 21 CFR 820.30 and ISO 13485 / ISO 14971
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