Job SummaryWe are looking for a highly skilled and experienced Mechanical Engineer with a strong background in mechanical design and integration of medical imaging 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 imaging products such as Diagnostic X-ray, Computed Tomography (CT), Image Guided Therapy (IGT), Mobile Surgery, and Mammography Systems. 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 imaging 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.
Work Experience
Essential Experience & Skills
Bachelor’s or master’s degree in Mechanical/Mechatronics Engineering or a 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 (e.g., Creo, 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 with sheet metal, plastics, castings, and precision mechanical assemblies.
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 Mathcad, LabView, or other Modeling Tools and experience
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.
Certifications in medical device design or quality systems (e.g., CQE, ASQ) are a plus.