Equipment Engineer

Quasar Medical; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A medical device company in Singapore is seeking a manufacturing engineer to improve and automate processes. The role involves increasing productivity, designing new tools, and ensuring compliance with industry standards. Candidates should have a Bachelor's in Engineering and 5-8 years of relevant experience, preferably in medical device manufacturing.

Qualifications

• 5 to 8 years’ experience in a high-volume production environment.
• Medical Device Manufacturing experience with knowledge of catheter production techniques is preferred.
• Knowledgeable in defining process capabilities and control charting.

Responsibilities

• Set up automation for manufacturing processes.
• Streamline manufacturing and increase productivity.
• Design tools, jigs, and fixtures for new production lines.
• Identify new automation opportunities and document processes.
• Troubleshoot automated processes or equipment errors.

Skills

Process automation

Product throughput improvement

Interpersonal skills

Statistical techniques

CAD software proficiency

Education

Bachelor in Engineering or similar technical field

Tools

CAD software

Job description

The scope of this role is to improve, streamline and automate manufacturing and other processes to reduce the need for human intervention and maximize efficiency. They are responsible for planning, implementing, and monitoring.

To support the Balloon Catheter line or Extrusion, Braid and Shaft Coil line in Singapore and develop, improve manufacturing processes by studying product and manufacturing methods in all areas of the Quasar Singapore.

Job Summary

The scope of this role is to improve, streamline, and automate manufacturing and other processes to reduce the need for human intervention and maximize efficiency. They are responsible for planning, implementing, and monitoring.

To support the Balloon Catheter line or Extrusion, Braid and Shaft Coil line in Singapore, develop and improve manufacturing processes by studying product and manufacturing methods in all areas of the Quasar Singapore.

Essential Duties and Responsibilities

• Sets up the automation of manufacturing processes governing the production and delivery of products.
• Streamline the manufacturing process, radically increase productivity, and make it as efficient as possible while still maintaining product quality and adhering to internal protocols and external regulations.
• Design, create, generate tools, jigs, and fixtures for the new line or customer or product; to improve, streamline and automate manufacturing and other processes to reduce the need for human intervention and maximize efficiency.
• Identify new opportunities for automation within the manufacturing process, develop and maintain clear and accurate documentation, design new automation equipment or processes or tools, jigs, and fixtures.
• Write reports outlining new concepts, testing outcomes, and ongoing efficiency.
• Troubleshoot automated processes or equipment when errors occur.
• Process troubleshooting, refine to improve product throughput, design of fixtures and assembly techniques.
• Process qualifications and validations, including equipment qualifications and material specifications.
• Responsible for Health & Safety within assigned areas to include accident investigation and corrective action.
• Investigate state-of-the-art process technologies and evaluate potential competitive advantage and the cost benefit of introduction.
• Oversee and drive Validation Activities.
• Maintain and comply with ISO13485, GMP and FDA regulations.

Authority

• Supervise Equipment Technicians.

Education, Experience, and Qualifications

• Availability to travel to sending site for duration of onsite training.
• Bachelor in Engineering or similar technical field with 5 to 8 years’ experience in a high-volume production environment. Medical Device Manufacturing experience with knowledge of catheter production techniques is preferred.
• Strong interpersonal skills with the ability to communicate effectively at all levels within the company.
• Proficient in DOE and statistical techniques.
• Knowledgeable in defining process capabilities and control charting.
• Writing of protocols for validations and qualifications including FMEA, MVP, IQ/OQ & TMV protocol preparation.
• Proficiency with CAD software is required.
• Knowledge of GMPs, ISO 9001, ISO13485 and the Medical Device Directives.
• Self-motivated and driver of change and innovation. Must be willing to work in a fast-paced environment with minimum supervision.