Project Engineer

YIXIN PRECISION ENGINEERING PTE LTD; Singapore; On-site; SGD 45,000 - 65,000; Full time

Job summary

A leading engineering firm in Singapore is seeking a dedicated Project Engineer to oversee contract manufacturing projects in the medical device sector. The role involves managing project schedules, ensuring compliance with design specifications and regulatory standards, and maintaining engineering documentation. Ideal candidates will have a degree in mechanical engineering and at least 2 years of relevant experience, along with strong communication and technical skills.

Qualifications

• Minimum of 2 years of working experience in project coordination/management.
• Strong understanding of medical device regulations and standards.
• Strong written and verbal communication skills in English.

Responsibilities

• Manage project schedule and oversee assembly processes.
• Lead or support IQ/OQ/PQ activities.
• Develop and maintain engineering documentation.

Skills

Project coordination

Understanding of ISO 13485

Technical communication

Knowledge of engineering principles

Education

Bachelor's degree or Diploma in mechanical engineering or related field

Job description

We are looking for a dedicated Project Engineer to join our team.

The Project Engineer will be responsible for overseeing engineering projects specialise in contract manufacturing in medical device, from conception through to completion.

You will work closely with cross‑functional teams to identify and resolve manufacturing issues, and to establish the process flow and inspection criteria of all the processing steps.

Improve production and demonstrate excellent project management skills to ensure that projects are completed on time, within budget, and meet quality standards.

Responsibilities

• Manage project schedule: to plan, coordinate, and oversee the assembly processes of medical devices or equipment, ensuring that production meets design specifications, regulatory standards ISO 13485(Medical Devices QMS) and FDA 21 CFR Part 820(QSR) and project deadlines.
• Lead or support IQ/OQ/PQ (Installation Qualification, Operational Qualification, and Performance Qualification) activities.
• Develop and maintain engineering documentation, including procedures, processes and quality plan, drawings, and specifications.
• Ensure work performed within desired quality and stipulated schedule.
• Ensure customer’s specification and requirements understood and executed as to provide good engineering solutions.
• Communicating with customers, interpreting their needs and requirements.

Requirements

• Bachelor’s degree or Diploma in mechanical engineering, Electrical Electronic & Engineering or a related field.
• Minimum of 2 years of working experience in project coordination/management or in related field.
• Strong understanding of Medical device regulations and standards.
• Strong written and verbal communication skills in English.
• Strong technical skills, including knowledge of engineering principles and practices.