Senior Engineer, Design

• 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) & 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 company's Quality Management System and ISO 13485.

• Perform other ad-hoc duties as assigned by immediate supervisor.

Education

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Mechatronics, or a closely related engineering discipline. A master's degree is advantageous.

Experience

• 6+ years in mechanical design/development of regulated medical devices, at least 2-3 years directly technically complex design work on endoscopes.

• Proven knowledge of DDC principles, Statistical Techniques, DFMA, DMAIC, DQE, IQ/OQ/PQ, and various manufacturing technologies and processes such as machining, injection moulding, extrusion and others.

Skills

• Excellent command of Computer Aided Software (CREO, SolidWorks or equivalent).

• Strong knowledge of technical standards (ASME, JIS etc).

• Experience in simulation software (Abaqus, Ansys etc.) is an advantage.

• Flexible shaft and bending section design, articulation mechanics, pull-wire routing, fatigue, friction, and deflection response.

• Small-scale mechanical assemblies, polymer and metal component selection, adhesives/bonding, interwelding, overwinding, and winder.

• Optical and fibre interfaces, including imaging/light-guide interfaces, working-channel geometry, irrigation/aspiration flow paths, and leak prevention.

• Innovative design, critical questioning, including required reprocessing, sterilization compatibility.

• Cross-functional collaboration, including manufacturability at volume, cost targets, packaging interfaces, and sterilization 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.