Medical Mechanical DHF
Job Description
Job Description – Mechanical Design Engineer
Company: HCLTech
Position: Mechanical Design – Lead / Technical Lead
Location: Chennai, Tamil Nadu
Experience: 2.5–10 Years
Industry: Medical Devices
Employment Type: Full-time
Drive Type: Recruitment Drive
Job Summary
HCLTech is looking for experienced Mechanical Design Engineers, Leads and Technical Leads with expertise in medical device design, Design Controls, Design Verification & Validation, DHF Remediation and Windchill PLM.
The ideal candidate should have strong mechanical engineering fundamentals and hands-on experience with medical device product development, sustaining engineering and regulatory documentation.
Key Responsibilities
Perform mechanical design and development activities for medical devices.
Work on Design Control, Design Verification (DV) and Design Validation (DV&V) activities.
Support sustaining engineering projects for medical device products.
Lead Change Qualification projects in collaboration with cross-functional and multicultural teams.
Develop test protocols, test plans and associated engineering documentation.
Review and ensure the quality of design deliverables, data summaries, interpretations and technical reports.
Perform proactive risk identification and mitigation planning.
Support project planning and independently manage assigned engineering activities.
Prepare and review technical documentation in accordance with applicable medical device processes.
Collaborate with cross-functional teams to ensure projects are delivered within quality and schedule requirements.
DHF Remediation Responsibilities
Perform Design History File (DHF) remediation activities.
Conduct gap assessments, including:
Testing Gap Assessment
Standards Gap Assessment
Requirements Gap Assessment
Identify missing or incomplete design documentation.
Support remediation and closure of DHF gaps.
Ensure documentation aligns with applicable medical device Design Control requirements.
Windchill PLM Responsibilities
Work with Windchill PLM in the medical device domain.
Manage and maintain product BOM structures.
Handle engineering Change Orders and change management processes.
Support product lifecycle and configuration management activities.
Ensure accurate product data and documentation within PLM systems.
Required Qualifications
B.E. / B.Tech or higher qualification in Mechanical Engineering.
Strong fundamentals in Mechanical Engineering.
For Sustaining Engineering roles, 3–7 years of experience in Medical Device Design Controls, Design Verification and Validation.
Overall experience range for the position: 2.5–10 years.
Required Skills
Medical Device Design Controls
Design Verification & Validation
DHF Remediation
Design History File management
Risk Management
Change Qualification
Requirements and standards gap assessment
Technical documentation and technical writing
Project management
Cross-functional collaboration
Strong oral and written communication
Software Tools
SolidWorks
2D Tolerance Stack-up
Windchill PLM
MS Word
MS Excel
MS PowerPoint
Preferred Skills
Knowledge of ISO 13485.
Experience in medical device regulatory and quality processes.
Experience working with multicultural cross-functional teams.
Strong interpersonal and communication skills.
Self-motivated with the ability to work independently.
Candidate Profile
The ideal candidate should be a technically strong Mechanical Design professional with experience in the medical device industry, particularly in Design Controls, DV/V, DHF remediation, sustaining engineering and/or Windchill PLM.
Application Details
Interested candidates should share their updated CV with the following details:
Current Company
Current CTC
Expected CTC
Notice Period
Current Location
Email: Katherinesylvia.k@hcltech.com
Drive Details
Drive Date: 26 July, 9:00 AM – 2:00 PM
Venue: HCLTech Elcot SEZ, New Cafeteria – 2nd Floor,
602/3, 138, Medavakkam High Road,
Sholinganallur, Chennai – 600119.
Note: The recruitment drive details provided above are from the original job announcement.
