Job Description
Project Engineer (Contract Manufacturing) – Singapore 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
What you’ll be doing
- 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
What we’re looking for
- 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
Preferred but not required: - 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
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Job Tags
Contract work,