Lead Mechanical Engineer

Quest Global

  • Nederland
  • Vast
  • Voltijds
  • 1 maand geleden
Job RequirementsJob 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 ExperienceEssential 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 (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.

Quest Global