Lead Mechanical Engineer

About the role

Lead Mechanical Engineer at Quest Global clients in Bengaluru, Karnataka, India, focused on mechanical design and integration of medical hardware and systems. The role involves translating system requirements into mechanical specifications, performing detailed modeling and tolerance analysis, overseeing prototype testing and validation, and ensuring regulatory compliance across the full product development lifecycle. The engineer collaborates with cross-functional R&D teams and supports regulatory submissions aligned with FDA and EU MDR requirements.

What you’ll do

• Design and development of sub-systems and assemblies for medical products
• Translate system requirements into mechanical specifications and design concepts
• Perform detailed mechanical modeling, tolerance stack-up analysis, and design optimization
• Oversee prototype development, testing, and validation of mechanical components
• Ensure compliance with medical device safety and quality standards during all design activities
• Generate and maintain detailed engineering drawings, BOMs, and design documentation
• Collaborate with cross-functional teams including electrical, software, and clinical engineers
• Support design reviews, risk analysis (DFMEA), and technical problem resolution

What you’ll bring

• Bachelor’s or master’s degree in Mechanical/Mechatronics Engineering or related field
• 8+ years of experience in mechanical design of medical devices, preferably in imaging systems like X-ray, CT, IGT, Mobile Surgery or Mammography systems
• Strong proficiency in 3D CAD tools such as Creo, SolidWorks, or NX
• Hands-on experience with Windchill PDM/PDLM
• Knowledge of Parametric Modeling, GD&T, and Tolerance Analysis
• Understanding of materials selection, thermal management, structural analysis, and ergonomics
• Experience designing sheet metal, plastics, castings, and precision mechanical parts
• Familiarity with IEC 60601, ISO 13485, and ISO 14971

Nice to have

• Exposure to EMC compliance considerations or clinical usability standards
• Knowledge of FEA tools like ANSYS or COMSOL for mechanical simulations
• Knowledge of DFMEA, PFMEA and other Risk Management Tools
• Knowledge of DOE, statistical analysis, and Minitab
• Familiarity with agile product development and regulatory audit preparedness

Skills

Education

Bachelor’s or master’s degree in Mechanical/Mechatronics Engineering or related field