DHF Remediation

Tata Elxsi; Pune District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Tata Elxsi seeks a DHF Specialist in Pune to own end‑to‑end DHF strategy, drive remediation for legacy devices and EU MDR programs, and ensure robust traceability across design inputs, risk, verification, validation, and usability engineering artefacts.

You will oversee DHF configuration and data integrity in PLM/ALM tools and serve as the primary DHF interface during FDA inspections and Notified Body audits.

Qualifications

• Bachelor’s or Master’s in Mechanical, Software, Electrical, or Biomedical engineering.
• 4 to 12 years in medical device design controls, DHF management, or quality engineering.
• Experience with FDA 21 CFR 820.30 and EU MDR.

Responsibilities

• Own end-to-end DHF strategy and execution across products; align with regulatory/quality expectations.
• Lead DHF remediation for legacy devices, EU MDR transitions, and M&A portfolios.
• Ensure bidirectional traceability across design inputs/outputs, risk, verification, validation, and usability artefacts.
• Provide technical oversight for risk management files and usability activities.
• Review verification and validation strategies, protocols, and regulatory reports.
• Govern DHF configuration, data integrity, and workflows in PLM/ALM tools like Windchill and Vault.
• Interface during FDA inspections, Notified Body audits, and customer assessments.

Skills

DHF management

Regulatory compliance

Design controls

FDA 21 CFR 820

V&V

Usability engineering

Mentoring

Education

Bachelor’s or Master’s in Mechanical, Software, Electrical, Biomedical

Tools

Windchill

Vault

PLM/ALM

Job description

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
• Complex V&V and design transfer activities