DHF Remediation
Tata Elxsi · Posted Nov 3
Design and technology services, product engineering, systems integration, and digital transformation solutions
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About the role
Tata Elxsi partners with medical device OEMs and technology companies on market research, human factor engineering, hardware and software engineering, verification and validation, and regulatory compliance, with an ISO 13485-certified Medical Device and Healthcare practice. The DHF Specialist role in Pune owns DHF strategy and remediation across products, maintains traceability across design and risk artefacts, governs PLM/ALM workflows, and serves as the DHF interface during audits and inspections.
What you will do
- 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.
Skills used in this role
What the employer is looking for
- 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.
- FDA 21 CFR 820.30, EU MDR ISO 13485, ISO 14971, IEC 62366‑1
- Complex V&V and design transfer activities
Benefits and support
- Compensation and benefits are detailed in the job posting
About Tata Elxsi
Tata Elxsi is a global provider of design-led technology services, specializing in product engineering, systems integration, and digital transformation. Operating across sectors like transportation, healthcare, and media, the company combines design thinking with advanced technologies such as AI, cloud, and IoT to help enterprises build connected, intelligent products.
- Industry
- Design Services
- Company size
- 11500+ employees
- Founded
- 1989
- Location
- Bengaluru, India
- Funding stage
- Public Company
Funding
Public Company · $0 raised
Leadership
Manoj Raghavan
CEO & Managing Director
Nalin Rana
Chief Financial Officer
Recent coverage
The Economic Times
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