R&D Intern

Key Responsibilities

• Review DHF indexes for completeness; identify missing, incomplete, or noncompliant records.
• Perform gap analyses and document discrepancies (missing deliverables, inconsistent versions/IDs, unclear evidence).
• Support design input collection and organization (user needs, risk management file, regulatory requirements, standards, labeling/IFU requirements).
• Confirm design inputs are clear/measurable, uniquely identified, and appropriately approved; separate user needs from design inputs.
• Review design outputs/specifications to ensure they are measurable/testable, follow the correct templates, and avoid vague/duplicate requirements.
• Map verification and validation evidence to design inputs/user needs; flag missing or unclear testing.
• Cross-check risk management documentation (e.g., FMEA/hazard analysis) to ensure risk controls are reflected in design inputs and specifications.
• Populate and refine DTM linkages (User Needs - Inputs - Outputs - Verification/Validation) and confirm forward/backward traceability.
• Perform document control and formatting checks (document numbers, revisions, approvals, SOP alignment) and help prepare submission-ready DHF packages.