Senior Mechanical Design Engineer – Medical Devices

Beecruit Pte Ltd; Singapore; On-site; SGD 67,000 - 78,000; Full time

Job summary

Beecruit Pte Ltd in Singapore seeks a Senior Mechanical Design Engineer to lead the mechanical design and development of regulated medical devices, with emphasis on flexible endoscopic systems.

You will take designs from user requirements and early concepts through detailed engineering, prototyping, verification and design transfer to manufacturing, ensuring ISO 13485 design controls.

Qualifications

• 6–9 years of mechanical design experience in regulated medical devices.
• 2–3 years leading technically complex designs or subsystems.
• Strong CAD skills: Creo or SolidWorks with GD&T and DFMA knowledge.
• Familiarity with ISO 13485 design controls.

Responsibilities

• Lead concept generation, mechanical design, prototyping and design transfer to manufacturing.
• Translate user needs into mechanical specs, CAD models, drawings and BOMs.
• Design distal-tip assemblies, articulation systems, insertion tubes and related parts.
• Develop 3D models, 2D drawings, GD&T and tolerance analyses.
• Build and evaluate prototypes and support verification testing.
• Lead design reviews, DFMEA, risk controls and CAPA investigations.
• Collaborate with Manufacturing Engineering on process feasibility and pilot builds.
• Maintain Design History File and risk documentation.
• Provide mentorship to junior engineers.
• Ensure compliance with ISO 13485 design controls.

Skills

Mechanical design

Regulated medical devices

Creo

SolidWorks

GD&T

DFMA

DOE

Project leadership

Mentorship

Education

Bachelor's Degree in Mechanical Engineering

Biomedical Engineering

Mechatronics

Master's degree advantageous

Tools

Creo

SolidWorks

Job description

Job Title: Senior Mechanical Design Engineer - Medical Devices

Employment Type: Permanent

Function: R&D / Product Development

(S$6,000 to S$7,000)

About the Role

We are seeking a Senior Mechanical Design Engineer to lead the mechanical design and development of regulated medical devices, with particular emphasis on flexible endoscopic systems, subsystems and accessories.

You will take designs from user requirements and early concepts through detailed engineering, prototyping, verification and eventual design transfer into manufacturing.

Key Responsibilities

• Lead concept generation, mechanical design, detailed engineering and prototype development.
• Translate user needs and system requirements into mechanical specifications, CAD models, drawings and BOMs.
• Design mechanisms for medical devices, including distal-tip assemblies, articulation systems, insertion tubes, bending sections, working channels, seals and irrigation pathways.
• Develop and review 3D CAD models, 2D drawings, GD&T and tolerance-stack analyses.
• Build and evaluate prototypes and support engineering verification testing.
• Apply DFM/DFA principles throughout the development lifecycle.
• Lead design reviews and contribute to DFMEA, risk controls, failure analysis and CAPA investigations.
• Work closely with Manufacturing Engineering on process feasibility, fixtures, pilot builds and design transfer.
• Maintain Design History File documentation including design inputs/outputs, drawings, specifications, BOMs and risk files.
• Provide technical mentorship to junior engineers and technicians.
• Ensure development activities comply with ISO 13485 design controls.

Requirements

• Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, Mechatronics or a closely related discipline. Master's advantageous.
• Approximately 6-9 years of mechanical design/product-development experience in regulated medical devices.
• At least 2-3 years leading technically complex designs or subsystems.
• Strong proficiency with Creo, SolidWorks or equivalent CAD software.
• Strong understanding of GD&T, DFMA, DOE, statistical techniques and mechanical design principles.
• Experience with manufacturing technologies such as machining, injection moulding and extrusion.
• Knowledge of flexible shafts, articulation mechanisms, small mechanical assemblies, polymers/metals, bonding, laser welding or sealing is highly advantageous.
• Experience with endoscopic or minimally invasive medical devices would be particularly valuable.