Senior Design Engineer (Medical Devices Manufacturing) / East

RecruitPedia Pte Ltd; Singapore; On-site; SGD 90,000 - 120,000; Full time

Job summary

Our client in Singapore is seeking an experienced R&D Design Engineer to develop mechanical designs, create CAD models and BOMs for medical device products. You will lead design reviews, perform FMEA and ensure manufacturability and quality controls across the project lifecycle.

The role requires hands-on prototyping, tooling coordination with suppliers and design transfer to manufacturing, with ISO 13485 practices guiding all activities.

Qualifications

• Minimum diploma or degree in Mechanical/Manufacturing engineering or related field.
• At least 6 years of mechanical design and product development experience.
• Experience in medical devices or regulated development is a plus.
• Strong hands-on mechanical design, prototyping and validation skills.
• Familiarity with Creo or SolidWorks and GD&T.

Responsibilities

• Convert product requirements into mechanical designs, specifications, drawings and BOMs.
• Develop precision mechanisms, flexible assemblies and mechanical components.
• Create and review 3D CAD models, 2D drawings, GD&T and tolerance calculations.
• Lead design reviews, risk assessments and FMEA to address design issues.
• Apply DFM/DFA, cost, manufacturability and serviceability considerations.
• Develop prototypes and conduct tests to assess design performance.
• Investigate problems, perform root-cause analysis and propose improvements.
• Collaborate with Manufacturing and suppliers on production feasibility and tooling.
• Support design transfer and product introduction to manufacturing.
• Lead mechanical design projects from concept to final design release.
• Maintain design records, specifications, drawings and BOMs.
• Provide technical guidance to junior engineers and ensure ISO 13485 compliance.

Skills

Design reviews

Root cause analysis

Leadership

Education

Diploma or Degree in Mechanical Engineering

Tools

Creo

SolidWorks

GD&T

Job description

Our client is one of the leading players in the medical devices manufacturing sector. Due to their current expansion plan, they are looking for a R&D Design Engineer to join their team, in hopes of developing the current high performing team. They are located in the East area.

Job Responsibilities:

• Convert product requirements into mechanical designs, specifications, drawings and BOMs.
• Develop precision mechanisms, flexible assemblies and mechanical components for product applications.
• Create and review 3D CAD models, 2D drawings, GD&T and tolerance calculations.
• Lead design reviews, risk assessments and FMEA to identify and address potential design issues.
• Apply DFM/DFA, cost, manufacturability and serviceability considerations during the design process.
• Develop prototypes and conduct engineering tests to assess design performance and reliability.
• Investigate technical problems, perform root-cause analysis and recommend design improvements.
• Work with Manufacturing and suppliers on production feasibility, assembly methods, tooling and pilot builds.
• Support design transfer and product introduction from engineering into manufacturing.
• Lead mechanical design projects from concept development through prototyping and final design release.
• Maintain accurate design records, specifications, drawings, BOMs and technical documentation.
• Provide technical guidance to junior engineers and ensure designs follow quality procedures, design controls and applicable ISO 13485 requirements.
• Perform any ad-hoc duties as assigned.

Requirements:

• Min Diploma or Degree in Mechanical/Manufacturing, or a related Engineering discipline.
• Min 6 years of relevant experience in mechanical design and product development.
• Experience in medical devices or other regulated product development will be an advantage.
• Strong hands-on experience in mechanical design, mechanism development and prototyping.
• Proficient in 3D CAD software, such as Creo, SolidWorks or equivalent.
• Knowledge of engineering standards and medical device design controls will be an advantage.