Equipment Engineer

Department: Engineering

Reports To: Manager Engineering

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 and develop, improves manufacturing processes by studying product and manufacturing methods in all areas of the Quasar Singapore.

Essential Duties and Responsibilities:

Include the following:

· Sets up the automation of manufacturing processes govern the production and delivery of products.

· To 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 fixture 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 maximise efficiency.

· Identify new opportunities for automation within the manufacturing process, developing and maintaining clear and accurate documentation, designing new automation equipment or processes or tools, jigs and fixtures.

· Writing reports outlining new concepts, testing outcomes, and ongoing efficiency.

· Troubleshooting automated processes or equipment when errors occur.

· Process troubleshooting, refinements 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.

· Required to perform rotating shift duties, including evening and night shifts,and may be assigned different roles within the team to support operational needs.

· Availability to travel to sending site for duration of onsite training.

· Any other project or duties as assigned.

Authority:

· Supervise Equipment Technicians

Education/Experience and Qualifications:

· 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.

Work Environment:

While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts. The noise level in the work environment is usually moderate.

Controlled Environment (Class 10K/100K cleanroom) and office area.