DHF Executive – Key Knowledge & Responsibilities

- 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 solid knowledge of engineering drawings, GD&T;, design documentation and QMS requirements.

📌 DHF Engineer (India)
🏢 S.H.Pitkar Orthotools
📍 India