Job Requirements

: Lead Mechanical Engineer

Job Summary

We are looking for a highly skilled and experienced Mechanical Engineer with a strong background in mechanical design and integration of medical hardware and systems. This role involves working closely with R&D; and cross-functional teams of Quest Global clients. The selected candidate will be responsible for mechanical design and integration efforts, ensuring regulatory compliance, and supporting the full product development cycle, including end-to-end lifecycle management of medical devices.

This role requires a deep understanding of both the technical and regulatory aspects of medical device development.

Key Responsibilities

· 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.

· Ensure manufacturability and serviceability of mechanical designs in alignment with product goals.

· Perform lifecycle engineering initiatives including design updates, obsolescence management, cost optimizations, and performance improvements of legacy products.

· Conduct the failure investigation, root cause analysis (RCA) and Corrective and Preventive Action (CAPA) processes for field issues.

· Collaborate with quality, service,



and reliability teams to implement corrective actions and design enhancements based on field performance data.

· Support regulatory submissions and design documentation in line with FDA and EU MDR requirements.

Essential Experience & Skills

· 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, Creo (Preferred), SolidWorks, NX etc.

· Good hands-on experience in Windchill PDM/PDLM tool

· Knowledge of Parametric Modeling, GD&T;, Tolerance Analysis etc.

· Valuable understanding of materials selection, thermal management, structural analysis, and ergonomics.

· Experience in designing sheet metal, plastics, castings, and precision mechanical parts.

· Familiarity with international standards such as IEC 60601, ISO 13485, and ISO 14971.

· Experience in design control, V&V; processes, and sustaining engineering activities.

· Hands-on experience with prototyping, testing, and working with contract manufacturers.

· Understanding of design for manufacturability (DFM), design for assembly (DFA), and design for service (DFS).

· Disciplined team worker, ability to work independently.

· Ability to present ideas and convince project team members.

· Be structured and self-organized.

· Excellent communication and articulation skills

· Strong analytical and problem-solving abilities

· Quality mindset in design and documentation

Desirable Experience & Skills

· 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, Minitab etc.

· Familiarity with agile product development and regulatory audit preparedness.

📌 Lead Mechanical Engineer (Bengaluru)
🏢 Quest Global
📍 Bengaluru