Tata Elxsi works with leading medical device OEMs and technology companies for market research and human factor engineering, hardware and software engineering, verification & validation, regulatory standards & compliance requirements along with technologies such as artificial intelligence, cloud and IoT. Tata Elxsi’s Medical Device and Healthcare practice is ISO 13485 certified. Role
- DHF Specialist Location
- Pune

Key Responsibilities
• Own end‑to‑end DHF strategy and execution across multiple products or programs, ensuring alignment with regulatory and quality expectations.
• Lead DHF remediation initiatives for legacy devices, EU MDR transition programs, and M&A; integrated portfolios.
• Ensure robust bidirectional traceability across design inputs, design outputs, risk management, verification, validation, and usability engineering artefacts.
• Provide technical oversight for risk management files, usability engineering activities (IEC 62366‑1), and benefit‑risk documentation.




• Review and approve verification and validation strategies, protocols, and reports for regulatory adequacy.
• Govern DHF configuration, data integrity, and workflows in PLM/ALM platforms, including tools like Windchill and Vault.
• Act as primary DHF interface during FDA inspections, Notified Body audits/reviews, and customer assessments.
• Provide technical guidance and mentoring to DHF engineers and cross‑functional teams. Qualifications

Education:
Bachelor’s or Master’s degree in Mechanical, Software, Electrical Engineering or Biomedical disciplines.

Experience:
4 to 12 years of progressive experience in medical device design controls, DHF management, or quality engineering, including program‑level responsibility. Technical Expertise
• FDA 21 CFR 820.30, EU MDR
• ISO 13485, ISO 14971, IEC 62366‑1
• Complex V&V; and design transfer activities

📌 DHF Remediation (India)
🏢 Tata Elxsi
📍 India