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.

✔ Good 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 regulatory requirements.

Lead the creation and execution of design verification protocols, summarize results, facilitate formal design reviews, and manage the verification section of the Design History File.

Only BE -Mechanical Walk-in Details

? Date: 1st August 2026

? Time: 9:30 AM – 12:30 PM

? Venue:

HCLTech ELCOT SEZ

Current Cafeteria, 2nd Floor

602/3, 138, Medavakkam High Road,

Sholinganallur, Chennai – 600119

? Contact Person: Mandru Divya Sri /Joy Renitha ? Interested candidates can share their updated CV to:

[email protected] / [email protected]

Please mention

Current Company

CTC

Expected CTC

Notice Period

Current Location

📌 Mechanical Design Engineer (Chennai)
🏢 HCLTech
📍 Chennai