Walk-in Drive | Mechanical Engineer – Design Control | Medical Devices | HCLTech - Chennai ?
Hiring | Mechanical Engineer – Design Control (Medical Devices) ?
? Location: Chennai
? ? Position: Mechanical Engineer – Design Control
? Experience: 3–5 Years

We are looking for talented Mechanical Engineers with experience in the Medical Device domain and strong expertise in Design Verification & Validation, Design Control, DHF, Change Control, and SAP/PLM systems.

Key Skills:
✅ Design Verification & Validation (DV&V;)
✅ Design Control Documentation
✅ Design History File (DHF)
✅ Change Control Management
✅ SAP / PLM Systems
✅ Medical Device Product Development
✅ ISO 13485 & ISO 14971
✅ 21 CFR Part 820.30
✅ Regulatory Compliance
✅ Design Reviews & Verification Protocols
Responsibilities:
• Develop and release Design Control documentation.
• Manage Change Control documents through SAP/PLM systems.
• Create and execute Design Verification protocols and summarize results.
• Facilitate formal Design Reviews.




• Maintain and manage the verification section of the Design History File (DHF).
• Ensure compliance with company policies, regulatory standards, and industry requirements.
Preferred Background:
✔ 3–5 years of Medical Device industry experience.
✔ Hands-on experience with Design Control, DHF, and Change Management processes.
✔ Positive understanding of ISO 13485, ISO 14971, and 21 CFR Part 820.30 requirements.

Detailed JD :

Seeking a Mechanical Engineer with experience in Medical Devices, specifically in Design Verification and Validation, Design Control, DHF, Change Control processes, and SAP/PLM systems.
Applicants should have relevant experience in the medical device sector, including managing Change Control documents through SAP/PLM.
- Familiarity with medical device standards such as 21 CFR Part 820.30, ISO 13485, and ISO 14971.
- Experience in developing and releasing design control documentation.
- Lead documentation of activities in line with company policies and re

📌 Mechanical Design Engineer (Chennai)
🏢 HCLTech
📍 Chennai