Design Engineer

Job Title: Design Engineer Medical Devices

Experience: 3 to 8 Years

Qualification: B.E / B.Tech Mechanical Engineering

Work Location: Madurai

Job Description:

The ideal candidate should have strong expertise in design control, design verification, and validation in compliance with medical device standards.

Key Responsibilities:

• Work on product design and development of medical devices
• Ensure compliance with Design Control processes as per regulatory standards (FDA, ISO 13485, etc.)
• Perform Design Verification & Validation (DV&V) activities
• Prepare and maintain design documentation, including DHF (Design History File)
• Collaborate with cross-functional teams such as Quality, Manufacturing, and Regulatory
• Conduct risk analysis (FMEA) and ensure mitigation actions
• Support product lifecycle activities, including design changes and sustaining engineering

Required Skills:

• Strong knowledge of Design Control, DV&V processes
• Experience in medical device product development
• Familiarity with regulatory standards (FDA, ISO 13485)
• Hands-on experience in CAD tools (Creo/SolidWorks/Catia)