Job Description

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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