Lead Mechanical Engineer

<strong>Job Requirements </strong><br><p>Job Description: Lead Mechanical Engineer</p><p>Job Summary</p><p>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.</p><p>Key Responsibilities</p><p>· Design and development of sub-systems and assemblies for medical products.</p><p>· Translate system requirements into mechanical specifications and design concepts.</p><p>· Perform detailed mechanical modeling, tolerance stack-up analysis, and design optimization.</p><p>· Oversee prototype development, testing, and validation of mechanical components.</p><p>· Ensure compliance with medical device safety and quality standards during all design activities.</p><p>· Generate and maintain detailed engineering drawings, BOMs, and design documentation.</p><p>· Collaborate with cross-functional teams including electrical, software, and clinical engineers.</p><p>· Support design reviews, risk analysis (DFMEA), and technical problem resolution.</p><p>· Ensure manufacturability and serviceability of mechanical designs in alignment with product goals.</p><p>· Perform lifecycle engineering initiatives including design updates, obsolescence management, cost optimizations, and performance improvements of legacy products.</p><p>· Conduct the failure investigation, root cause analysis (RCA) and Corrective and Preventive Action (CAPA) processes for field issues.</p><p>· Collaborate with quality, service, and reliability teams to implement corrective actions and design enhancements based on field performance data.</p><p>· Support regulatory submissions and design documentation in line with FDA and EU MDR requirements.</p><p>Essential Experience & Skills</p><p>· Bachelor’s or master’s degree in Mechanical/Mechatronics Engineering or related field</p><p>· 8+ years of experience in mechanical design of medical devices, preferably in imaging systems like X-ray, CT, IGT, Mobile Surgery or Mammography systems.</p><p>· Strong proficiency in 3D CAD tools, Creo (Preferred), SolidWorks, NX etc.</p><p>· Good hands-on experience in Windchill PDM/PDLM tool</p><p>· Knowledge of Parametric Modeling, GD&T, Tolerance Analysis etc.</p><p>· Good understanding of materials selection, thermal management, structural analysis, and ergonomics.</p><p>· Experience in designing sheet metal, plastics, castings, and precision mechanical parts.</p><p>· Familiarity with international standards such as IEC 60601, ISO 13485, and ISO 14971.</p><p>· Experience in design control, V&V processes, and sustaining engineering activities.</p><p>· Hands-on experience with prototyping, testing, and working with contract manufacturers.</p><p>· Understanding of design for manufacturability (DFM), design for assembly (DFA), and design for service (DFS).</p><p>· Disciplined team worker, ability to work independently.</p><p>· Ability to present ideas and convince project team members.</p><p>· Be structured and self-organized.</p><p>· Excellent communication and articulation skills</p><p>· Strong analytical and problem-solving abilities</p><p>· Quality mindset in design and documentation</p><p>Desirable Experience & Skills</p><p>· Exposure to EMC compliance considerations, or clinical usability standards.</p><p>· Knowledge of FEA tools like ANSYS or COMSOL for mechanical simulations.</p><p>· Knowledge of DFMEA, PFMEA and other Risk Management Tools</p><p>· Knowledge of DOE, statistical analysis, Minitab etc.</p><p>· Familiarity with agile product development and regulatory audit preparedness.</p><br><br>