About this role
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.