Senior Engineer, Design/ Design verification

Fong's Engineering & Manufacturing Pte Ltd; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

Fong's Engineering & Manufacturing Pte Ltd in Singapore seeks an experienced Mechanical Design Engineer to lead endoscope system development from concept to prototype validation.

You will translate user needs into measurable specifications, create CAD models and drawings, perform GD&T and tolerance analyses while ensuring DFMA and sterilization compatibility in a regulated medical-device environment.

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Mechatronics or related engineering discipline; master's preferred.
• 6+ years in mechanical design/development of regulated medical devices, with 2–3 years on endoscopes.
• Proven knowledge of DDC principles, Statistical Techniques, DFMA, DMAIC, DQE, IQ/OQ/PQ, and various manufacturing technologies.
• Proficient in CREO/SolidWorks; familiarity with ASME/JIS; simulation software such as Abaqus/Ansys.
• Cross-functional collaboration, manufacturability at volume, packaging interfaces, and sterilization compatibility.

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) & 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.

Skills

CREO

SolidWorks

Abaqus

Ansys

3D CAD

GD&T

DFM

DFA

Endoscope design

Fatigue analysis

Sterilization compatibility

Cross-functional collaboration

Prototyping

Materials selection

Education

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Biomedical Engineering

Mechatronics

Master's degree (advantageous)

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.