DHF Specialist

Tata Elxsi is among the world’s leading providers of design and technology services across industries, including automotive, broadcast, communications, healthcare, and transportation. Tata Elxsi works with leading OEMs and suppliers in the automotive and transportation industries for R&D, design, and product engineering services from architecture to launch and beyond.
Role Purpose
Develop, review, and maintain Design History File (DHF) documentation for tubing systems and electromechanical devices. Ensure compliance with ISO 13485, 21 CFR 820, and ISO 14971 through robust design controls, risk management, and traceability.
Key Responsibilities
Design Controls
Author and review DHF elements: User Needs, Design Inputs/Outputs, Design Reviews, Verification & Validation (V&V) plans.
Maintain traceability matrix linking requirements to risk and V&V.
Risk Management
Develop and review Risk Management Files per ISO 14971.
Perform hazard analysis, FMEA, and risk-benefit assessments.
Usability & Human Factors
Incorporate usability engineering principles into design documentation.
Compliance & Standards
Ensure adherence to ISO 13485, 21 CFR 820, and applicable IEC standards.
Tools & Documentation
Use Vault and Polarion for document control and requirements management.
Maintain audit-ready documentation and version control.
Required Skills & Qualifications
Bachelor’s degree in Engineering, Biomedical, or related field.
2 - 6 years experience in DHF documentation and design controls.
Strong knowledge of: ISO 13485, 21 CFR 820.
ISO 14971 risk management, hazard analysis, FMEA.
Experience with traceability, V&V planning, usability documentation.
Preferred
Experience with tubing systems and electromechanical devices.
Familiarity with IEC 60601 series and usability standards (IEC 62366-1).
Strong technical writing and cross-functional collaboration skills.

Work arrangement
No