Senior Engineer, Design

fong's engineering and manufacturing pte ltd; Singapore; On-site; SGD 110,000 - 170,000; Full time

Job summary

fong's engineering and manufacturing pte ltd in Singapore seeks a senior mechanical design engineer to lead endoscope subsystem development, mechanism design, and design verification for regulated medical devices.

You're responsible for translating user needs into mechanical requirements, creating CAD models and drawings, leading design reviews, ensuring DFM/DFA and sterilization compatibility, and mentoring junior engineers while collaborating with manufacturing and QA teams.

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Mechatronics, or closely related field. A master's degree is advantageous.
• 6+ years in mechanical design of regulated medical devices, with 2-3 years on endoscopes.
• Knowledge of DFM, DFA, statistics, DFMA, DMAIC, DQE, IQ/OQ/PQ.

Responsibilities

• Lead mechanical design of endoscope mechanisms and subsystems.
• Translate needs into mechanical requirements, drawings, and BOMs.
• Develop and evaluate prototypes; plan tests with Test Engineer.
• Lead design reviews; contribute to FMEA and CAPA.

Skills

CAD software

Standards knowledge

Simulation tools

Endoscope design

Materials selection

Optical interfaces

Sterilization compatibility

Cross-functional collaboration

Technical communication

Root-cause analysis

Education

Bachelor's in Mechanical/BME/Mechatronics

Master's preferred

Tools

CREO

SolidWorks

Abaqus

Ansys

Job description

• 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.