Mechanical Design Engineer (Robotic Endoscope Systems)

Job Responsibilities

• Lead concept generation, mechanism design, detailed design, prototype development and technical problem-solving for robotic endoscope systems, subsystems and accessories
• Translate user needs and system-level design inputs into measurable mechanical requirements, specifications, CAD models, drawings, BOMs and subsystem interfaces
• Design critical endoscope mechanisms, such as distal-tip deflection assemblies, articulation wrists, insertion tubes, bending sections, working channels, high-precision linkages, control-handle mechanisms, seals and migration pathways
• Create and review 3D CAD models, assemblies, 2D drawings, GD&T, tolerance-stack analyses, material specifications and component-level requirements
• Develop and evaluate prototypes, plan engineering confidence tests and work with the Test Engineer to execute verification activities
• Apply Design for Manufacturability (DFM) and Design for Assembly (DFA), cost, serviceability, reliability and supplier capability considerations from early concept selection through design release
• Lead design reviews and contribute to Design FMEA, risk control definition, design-change impact assessments, failure analyses and CAPA investigations
• Work with the Manufacturing Engineer on process feasibility, assembly methods, fixtures, design transfer and pilot builds
• Maintain controlled design documentation, including design inputs/outputs, drawings, specifications, BOMs, test reports, vendor records and DHF deliverables
• Provide technical mentorship to junior mechanical engineers, technicians and external suppliers
• Follow Design Control for medical devices to ensure compliance with the company’s Quality Management System and ISO 13485
• Perform other ad-hoc duties as assigned by the immediate supervisor

Job Requirements

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Mechatronics or a closely related engineering discipline (a master’s degree is advantageous)
• 6 years of mechanical design and development experience in regulated medical devices, including at least 2 years directly on technically complex endoscope design
• Proven knowledge of DDC principles, statistical techniques, DFMA, DMAIC, DQE and IQ/OQ/PQ
• Knowledge of manufacturing technologies and processes such as machining, injection moulding and extrusion
• Excellent command of CAD software (Creo, SolidWorks or equivalent)
• Strong knowledge of technical standards (ASME, JIS, etc.)
• Experience in simulation software (Abaqus, Ansys, etc.) is an advantage
• Experience in flexible shaft and bending section design, articulation mechanics, pull-wire routing, fatigue, friction and deflection response
• Experience in small-scale mechanical assemblies, polymer and metal component selection, adhesives/bonding, interwelding, overwinding and winder
• Familiarity with optical and fibre interfaces, including imaging/light-guide interfaces, working-channel geometry, irrigation/aspiration flow paths and leak prevention
• Innovative design thinking and critical questioning, including reprocessing and sterilisation compatibility requirements
• Cross-functional collaboration, including manufacturability at volume, cost targets, packaging interfaces and sterilisation compatibility
• Excellent written and verbal communication for protocol authoring, report writing and cross-functional collaboration
• Problem-solving mindset, with the ability to drive root-cause investigations and design improvements

Interested candidates are invited to apply via the “Apply Now” button.

We regret that only shortlisted candidates will be notified.

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EA Personnel: Ching Ning Xin
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