Product Engineer (Medical Devices)

Recruit Expert Pte Ltd; Singapore; On-site; SGD 39,000 - 47,000; Full time

Job summary

Recruit Expert Pte Ltd in Singapore is seeking a Biomedical/Mechanical/Electrical Engineer to lead sustaining engineering, manage design changes, and ensure regulatory compliance for medical devices.

You will conduct design validation, FMEA, root cause investigations, and support cost reduction and new product development through materials and design improvements. Strong CAD skills and cross-functional collaboration are essential for success.

Qualifications

• Degree in Biomedical, Mechanical or Electrical Engineering.
• At least 3 years of product design and thermoplastics experience in the medical device industry or related manufacturing environment.
• Proficiency in CAD design tools, preferably SolidWorks.
• Knowledge of statistical methods and product testing.
• Strong analytical, problem-solving, communication and interpersonal skills.

Responsibilities

• Manage product sustaining engineering activities, design changes and design verification to ensure compliance with customer specifications and applicable medical device regulatory standards.
• Conduct product testing, design validation, failure mode and effects analysis (FMEA), and root cause investigations to resolve design issues and improve product quality, reliability and shelf life.
• Coordinate cross-functional engineering projects with process, packaging and other departments, monitoring project timelines, costs and technical deliverables.
• Provide technical support for existing medical device products, addressing customer complaints, regulatory compliance issues, CAPA activities and continuous improvement initiatives.
• Support cost reduction and new product development initiatives by evaluating materials, technologies and design improvements.

Skills

Analytical skills

Problem solving

Communication

Interpersonal skills

Collaboration

Education

Biomedical Engineering

Mechanical Engineering

Electrical Engineering

Tools

SolidWorks

Job description

Roles & Responsibilities:

• Manage product sustaining engineering activities, design changes and design verification to ensure compliance with customer specifications and applicable medical device regulatory standards.
• Conduct product testing, design validation, failure mode and effects analysis (FMEA), and root cause investigations to resolve design issues and improve product quality, reliability and shelf life.
• Coordinate cross-functional engineering projects with process, packaging and other departments, monitoring project timelines, costs and technical deliverables.
• Provide technical support for existing medical device products, addressing customer complaints, regulatory compliance issues, CAPA activities and continuous improvement initiatives.
• Support cost reduction and new product development initiatives by evaluating materials, technologies and design improvements.

Requirements:

• Degree in Biomedical, Mechanical or Electrical Engineering.
• At least 3 years of product design and thermoplastics experience in the medical device industry or related manufacturing environment.
• Proficiency in CAD design tools, preferably SolidWorks, with knowledge of statistical methods and product testing.
• Strong analytical, problem-solving, communication and interpersonal skills, with the ability to collaborate across departments and external stakeholders.

Salary: $3,500 to $4,200

Ref: 1869750

EA Licence: 19C9701
Registration: R1326740

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