Lead the development, organization, and maintenance of Design History File (DHF) documentation in compliance with 21 CFR 820.30, combination product requirements, and internal procedures
Author and technically own key design control deliverables, including design inputs, system requirements, design outputs and specifications, verification and validation protocols, reports, and design review documentation
Ensure robust traceability between user needs, drug–device interfaces, risk controls, design outputs, and verification and validation activities
Collaborate with cross functional teams such as R&D, Analytical, Quality, manufacturing, CMC and Regulatory Affairs to ensure consistent technical intent across development artifacts
Capture design rationale and engineering decisions in a clear, defensible manner suitable for regulatory review
Support integration of device development activities within broader drug development timelines and program milestones
Assess and manage documentation and technical impacts of design changes throughout development and lifecycle management
Participate as a technical contributor in risk management activities, design reviews, and cross-functional working sessions
Support inspection and audit readiness by ensuring DHF completeness, clarity, and consistency across combination product documentation
