Engineer (Process)

Roles & Responsibilities

Job Responsibilities :

1. Process Development : Develop and design manufacturing processes for precision engineering products using CAD / CAM, ensuring they meet quality and efficiency standards. Additionally, create detailed process flow diagrams, layouts, and work instructions to guide production teams. Special attention will be given to ensuring processes comply with ISO 13485 standards, which are crucial for the biomedical industry.

2. Process Monitoring and Analysis : Monitor process performance through regular data collection and analysis. Identify and address process deviations, implementing corrective actions to maintain process stability and product quality. Conduct root cause analysis for process-related issues and implement preventive measures, with a focus on meeting ISO 13485 standards.

3. Process Optimization : Conduct thorough process simulations and analyze data to identify bottlenecks and areas for improvement. Implement process improvements to enhance productivity, reduce waste, and lower production costs. Utilize Lean Manufacturing and Six Sigma methodologies to drive continuous improvement initiatives, ensuring alignment with ISO 13485 requirements for medical devices.

4. Cross-Functional Collaboration : Work closely with production and quality assurance teams to ensure seamless integration of new processes. Participate in cross-functional meetings to discuss project progress, challenges, and solutions. Collaboration will also involve ensuring that all processes meet the stringent regulatory requirements of the biomedical industry.

5. Documentation and Compliance : Participate in the development and maintenance of process documentation, including standard operating procedures (SOPs), work instructions, and process control plans. Ensure all processes comply with industry standards, safety regulations, and company policies. This includes adhering to ISO 13485 standards, which are essential for maintaining quality management systems in the biomedical sector.

6. Technical Support and Training : Provide technical support to production staff, troubleshooting process-related issues and offering solutions. Conduct training sessions for relevant staff on Mastercam, new processes, equipment, and best practices. Training will also cover compliance with ISO 13485 standards to ensure all team members are aware of the regulatory requirements in the biomedical industry.

7. Continuous Improvement : Lead and participate in continuous improvement projects aimed at enhancing product quality, reducing cycle times, and increasing overall efficiency. Stay updated with the latest advancements in process engineering and precision manufacturing technologies. Continuous improvement efforts will also focus on maintaining compliance with ISO 13485 standards to ensure the highest quality in biomedical products.

8. Operation of CNC machines : Perform Setup and operate CNC machining equipment as required, ensuring precision and accuracy in the manufacturing process. Troubleshoot any issues that arise during machining to maintain high-quality standards.

9. Additional Duties : Perform any other relevant duties and responsibilities as assigned by the superior. This may include participating in special projects, providing support to other departments, and contributing to the overall success of the company.

Job Requirements :

1. Educational Background : Diploma or Bachelor’s degree in Engineering, Industrial Management, or a related field. Professional certifications and experience in the biomedical or precision engineering sectors.(eg. ISO 13485, 9001) are highly desirable.

2. Experience in Engineering System : Proven experience in related knowledge of biomedical engineering principles and Computer literate with CAD / CAM solutions, Solidworks and MasterCam software for design and modelling in small to medium-sized enterprises (SMEs) is advantageous.

3. Knowledge of Engineering Standards : Strong understanding of engineering systems, standards, and project management methodologies. Familiarity with relevant regulations and certifications specific to the manufacturing industry is essential.

4. Analytical and Problem-Solving Skills : Excellent analytical skills to interpret engineering data, identify root causes of defects, and implement effective solutions. Proficiency in using engineering analysis tools and software.

5. Communication and Leadership Skills : Strong communication skills to effectively convey engineering issues, collaborate with cross-functional teams, and present findings to senior management. Proven leadership abilities to manage engineering team and drive continuous improvement.

Tell employers what skills you have

Troubleshooting

Lean Manufacturing

Manufacturing Processes

ISO

Root Cause Analysis

CNC

Process Engineering

Machining

Process Optimization

Simulations

Regulatory Requirements

Process Control

Manufacturing

Six Sigma

Technical Support