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
👉 Not the right role? Upload your profile for other exciting opportunities here: Dart Solutions Careers
