R&D Team

Ambition Singapore; Singapore; On-site; SGD 90,000 - 140,000; Full time

Job summary

Ambition Singapore seeks a senior mechanical design engineer to lead design and development of regulated medical devices, including endoscope mechanisms and subassemblies. You will translate user needs into measurable requirements, CAD models, drawings, BOMs and interface specs.

You will drive DFMA/ DFA, lead design reviews, perform FMEA, risk assessments, CAPA investigations, and mentor junior engineers while ensuring ISO 13485 compliance and Design Control.

Qualifications

• 6-9 years in mechanical design/development of regulated medical devices.
• 2-3 years leading technically complex design work or subsystems.
• Knowledge of DFMEA, risk-control definition, and GD&T.

Responsibilities

• Lead design reviews and contribute to FMEA, CAPA investigations, and design-change assessments.
• Translate user needs into measurable mechanical requirements, CAD models, drawings, BOMs, and interfaces.
• Develop and review 3D CAD models, assemblies, 2D drawings, tolerances, and material specs.
• Plan and execute verification activities with Test Engineers and maintain DHF deliverables.
• Mentor junior engineers, technicians, and external suppliers; ensure Design Control and ISO 13485 compliance.

Skills

DOE Principles

Statistical Techniques

DFMA

GD&T

Manufacturing Technologies

Leadership

Mentorship

Education

Bachelor's degree in Mechanical Engineering

Master's degree (advantageous)

Tools

SolidWorks

3D CAD

Job description

Lead concept generation, mechanism design, detailed design, prototype development, and technical problem-solving for flexible endoscope systems, subassemblies, 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 wires, insertion tubes, bending sections, working channels, light-guide/optics interfaces, control-handle mechanisms, seals, and irrigation 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 analysis, 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, risk files, design-review records, and DHF deliverables.

Provide technical mentorship to junior mechanical engineers, technicians, and external suppliers.

Follow Design Control for medical devices to ensure compliance to company's Quality Management System and ISO 13485.

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

Requirements

Education

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

Experience

6-9 years in mechanical design/development of regulated medical devices; at least 2-3 years leading technically complex design work or subsystems.

Proven knowledge of DOE principles, Statistical Techniques, DFMA, DMEA, DEA, GD&T and various manufacturing technologies and process such as machining, injection moulding, extrusion and etc.