Singapore | Project Engineering | Medical Device Manufacturing | ISO 13485 | FDA QSR | Contract Manufacturing | IQ/OQ/PQ
SGD 3,000 – 4,500
Take ownership of engineering and manufacturing projects for high-precision medical device components, supporting activities from prototyping to cleanroom assembly while ensuring compliance with medical device quality and regulatory standards. This role is ideal for engineers with strong project coordination skills, technical documentation experience, and exposure to regulated manufacturing environments.
About the Company
The company is a trusted contract manufacturer specializing in precision engineering solutions for the medical device industry. Utilizing advanced technologies such as Metal Injection Molding (MIM), CIM, and 3D Metal Printing, the team supports global healthcare clients in developing innovative and market-ready medical products. Their operations are supported by strong quality systems and compliance standards including ISO 13485 and FDA QSR.
What’s in it for you
Take ownership of end-to-end project execution within a regulated medical manufacturing environment
Support and lead validation activities including IQ/OQ/PQ for cleanroom production processes
Collaborate directly with customers to understand requirements and deliver tailored engineering solutions
Contribute to the development of advanced healthcare technologies with global impact
Work alongside cross-functional teams focused on quality, technical excellence, and continuous improvement
Key Responsibilities
Manage and coordinate engineering projects from prototype to production stage
Plan, oversee, and support medical device assembly and manufacturing activities
Ensure all production processes comply with design specifications, quality plans, and regulatory standards
Lead or support validation activities including IQ/OQ/PQ documentation and execution
Develop and maintain engineering documentation, SOPs, process flows, and inspection criteria
Communicate customer requirements clearly to internal teams and ensure proper implementation
Liaise with production, quality, and engineering teams to resolve technical and manufacturing issues
Provide technical support for troubleshooting, process improvements, and production-related concerns
Monitor project schedules, deliverables, and quality performance to ensure successful execution
Requirements
Degree or Diploma in Mechanical Engineering, Electrical & Electronics Engineering, or related discipline
Minimum 2 years of experience in project engineering, project coordination, or manufacturing environments
Strong technical knowledge of engineering principles and manufacturing documentation
Familiarity with medical device quality systems and regulated manufacturing environments
Good communication and stakeholder management skills
Strong analytical thinking, troubleshooting, and problem-solving abilities
Able to work independently and manage multiple projects effectively
Preferred Experience
Experience in MIM, CIM, tooling, cleanroom injection molding, or 3D metal printing processes
Prior exposure to contract manufacturing or precision engineering industries
Familiarity with ISO 13485, FDA QSR, and FDA 21 CFR Part 820 compliance standards
Experience supporting cleanroom manufacturing and validation activities
Dart Solutions was founded in 2017 with a mission to allow our clients access to our large network and database of professionals and top talents across industries and sectors within the Marine, Engineering, IT & Digitalization, Sales & Marketing and a suite of other corporate services helping them find the best talents possible. Everything the market needs, we've got it covered. All your hiring needs in one place.
From permanent, interim and contract recruitment to executive searches, our suite of services and expertise has helped many companies of all sizes hire with confidence the best they need, when they need it.
With strategically located headquarters springing up in Singapore overlooking the Asia Pacific, you can be assured our area of coverage, expertise and the people in our network has always extended beyond the shores of Singapore spanning across the entire Asia Pacific, ensuring our clients and candidates receive the best service, advice and results, always.