Lead Mechanical Engineer

Job Requirements

Job Description: 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.
• Good 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.