Project Engineer (CM) | Medical Devices
- Singapore
- $3,000 per month
- Permanent
- Full-time
📍Singapore | Project Management, Engineering, Medical Device QMS
Take the lead in delivering high-precision healthcare components — from prototyping to cleanroom assembly — and help bring next-gen medical technologies to life.About the Company The company is a trusted contract manufacturer specializing in precision engineering for the medical device industry. Known for delivering high-quality components through technologies like Metal Injection Molding (MIM) and 3D Metal Printing, the team supports international clients in bringing impactful, market-ready healthcare innovations to the global stage.
Their operations are built on robust quality systems and regulatory compliance, including ISO 13485 and FDA QSR, ensuring excellence from concept to production.About the Role As a Project Engineer (Contract Manufacturing), you will manage engineering projects from start to finish — translating customer specifications into practical solutions, ensuring compliance with medical device standards, and coordinating internal resources across the production lifecycle.
You’ll play a key role in ensuring that projects are delivered on time, within budget, and in line with design, quality, and regulatory requirements.What’s in it for you
- Take ownership of end-to-end project execution in a regulated, quality-driven environment
- Support and lead validation activities (IQ/OQ/PQ) and documentation for cleanroom production
- Collaborate directly with clients to interpret requirements and deliver tailored solutions
- Contribute to the development of cutting-edge healthcare products with real-world impact
- Be part of a cross-functional team committed to technical excellence, customer satisfaction, and continuous improvement
- Plan, coordinate, and oversee assembly processes for medical devices
- Ensure all production activities align with design specs, quality plans, and ISO 13485/FDA 21 CFR Part 820 standards
- Lead/support validation activities such as IQ/OQ/PQ
- Develop and maintain engineering documentation, process flows, and inspection criteria
- Ensure customer requirements are fully understood, communicated, and implemented
- Liaise with internal teams to troubleshoot issues and meet schedule/quality commitments
- Provide technical support to ensure production issues are resolved effectively
- Degree/Diploma in Mechanical Engineering, Electrical & Electronics, or related field
- Minimum 2 years of experience in project coordination or management
- Strong technical knowledge of engineering principles and documentation
- Understanding of medical device regulatory standards
- Excellent written and spoken communication skills in English
- Strong attention to detail and problem-solving skills
- Experience in MIM, CIM, 3D metal printing, tooling, or cleanroom plastic injection
- Prior experience in a contract manufacturing environment
- Familiarity with ISO 13485 and FDA QSR compliance