DHF Engineer

• Complete knowledge of Design History File (DHF) process and documentation
• Design & Development Planning
• Design Inputs – product requirements, functional, safety, regulatory and user requirements
• Design Outputs – drawings, specifications, BOM, manufacturing/process specifications
• Design Reviews – planning, documentation, action tracking and closure
• Design Verification (DV) – protocols, reports and traceability
• Design Validation (PV) – protocols, reports and validation evidence
• Risk Management File – DFMEA, UFMEA, Hazard Analysis and Risk Management Report
• Design changes and engineering change control
• Design Verification & Validation traceability
• GSPR / Essential Requirements compliance documentation
• Comparative / equivalence assessment documentation, where applicable
• Clinical Evaluation Report (CER) support and documentation
• Declaration of Conformity (DoC) documentation support
• DHF document review, indexing, revision control and record maintenance
• Design Transfer – ensuring approved design outputs are properly transferred to Production/Manufacturing
• Coordination with R&D/Design, Production, Quality, Regulatory and Engineering
• Knowledge of ISO 13485 and medical-device design-control requirements
• Ability to maintain complete Design Traceability Matrix (DTM) from Design Input → Output → Verification → Validation → Design Transfer

Preferred experience: 2–4 years in a medical device / orthopedic manufacturing company, with strong knowledge of engineering drawings, GD&T, design documentation and QMS requirements.