REQUIREMENTS

• Bachelor’s degree in Mechanical Engineering, Electrical & Electronic Engineering, or a related field.
• Minimum 2 years of experience in project coordination, project management, or a related engineering role.
• Solid understanding of medical device regulations and standards.
• Strong technical foundation in engineering principles and practices.
• Excellent written and verbal communication skills in English.
• Strong problem-solving skills with the ability to work independently and in a team environment.

ABOUT THE ROLE

We are seeking a dedicated and detail-oriented Project Engineer to join our team. The successful candidate will be responsible for managing and executing engineering projects in the medical device contract manufacturing sector, from concept through to completion. This role requires close collaboration with cross-functional teams to identify and resolve manufacturing issues, establish process flows, define inspection criteria, and implement improvements to ensure projects are delivered on time, within budget, and in compliance with quality standards.

KEY RESPONSIBILITIES

• Plan, coordinate, and manage project schedules, ensuring assembly processes of medical devices and equipment meet design specifications, ISO 13485 (Medical Devices QMS), and FDA 21 CFR Part 820 (QSR) requirements.
• Lead or support IQ/OQ/PQ (Installation Qualification, Operational Qualification, Performance Qualification) activities.
• Develop, review, and maintain engineering documentation, including procedures, process flows, quality plans, technical drawings, and specifications.
• Ensure work is carried out according to quality, regulatory, and schedule requirements.
• Understand and execute customer specifications, delivering effective engineering solutions.
• Communicate proactively with customers to interpret and address their needs and requirements.