The DHF Engineer is responsible for execution and independent management of design control documentation activities across medical device development and sustaining engineering programs. The role focuses on maintaining complete, traceable, and inspection‑ready DHFs in compliance with FDA, EU, and international standards. The position requires a strong technical understanding of design controls, verification and validation, risk management, and digital PLM environments.
Key Responsibilities :
- Execute and maintain DHF artifacts including design plans, design inputs, design outputs, design reviews, verification, validation, and design transfer records in accordance with 21 CFR 820.30 and ISO 13485.
- Establish and maintain bidirectional traceability between user needs, system/software requirements, risk controls, and verification and validation evidence.
- Author and update DHF documentation for new product development, sustaining engineering changes, and legacy product remediation.
- Support risk management activities, including hazard analysis, DFMEA, risk control implementation, and residual risk documentation in alignment with ISO 14971.
- Prepare and review verification and validation protocols, test reports, and traceability matrices.
- Execute DHF updates within PLM/ALM systems, ensuring compliance with electronic documentation and change control requirements.
- Support design reviews, internal audits, and external regulatory inspections by providing DHF evidence and technical explanations.
Qualifications :
Education: Bachelor's or Master's degree in Biomedical, Mechanical, Electrical, Software Engineering, or related disciplines.
Experience: 3 to 7 years of hands‑on experience in medical device design controls, DHF execution, or quality engineering roles.
Technical Knowledge
- FDA 21 CFR 820.30 (Design Controls)
- ISO 13485, ISO 14971
- Design verification and validation lifecycle
- Change control and sustaining engineering
Tools & Systems
- PLM/ALM/DHF: Windchill, Vault (experience preferred)
- Risk Management Tools
- MS Excel, Word, PowerPoint for traceability and documentation
