Automation Engineer – Medical Device Manufacturing

Quasar Medical | Medical Device Manufacturer; Singapore; Sur place; SGD 70 000 - 120 000; Plein temps

Résumé du poste

Quasar Medical in Singapore seeks an experienced Automation Engineer to improve, streamline and automate manufacturing and related processes, reducing human intervention and maximizing efficiency. You will support Balloon Catheter, Extrusion, Braid and Shaft Coil lines in Singapore and advance manufacturing methods across Quasar Singapore.

Responsibilities include setting up automated processes, standardizing tooling and fixtures, qualifying processes, and ensuring compliance with GMP, ISO13485

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.
• Proficiency with CAD software is required.
• Knowledge of GMPs, ISO 9001, ISO13485 and the Medical Device Directives.
• Writing protocols for validations and qualifications including FMEA, MVP, IQ/OQ & TMV protocol preparation.
• Strong interpersonal skills with the ability to communicate effectively at all levels within the company.

Responsabilités

• Set up the automation of manufacturing processes to govern the production and delivery of products.
• Streamline manufacturing processes to radically increase productivity while maintaining quality and regulatory compliance.
• Design, create, generate tools, jigs and fixtures for new lines or products and automate processes.
• Identify opportunities for automation and develop documentation, equipment, processes, or fixtures.
• Write reports on new concepts, testing outcomes, and ongoing efficiency.
• Troubleshoot automated processes or equipment when errors occur.
• Perform process qualifications and validations including equipment qualifications and material specifications.
• Oversee and drive validation activities and maintain ISO13485, GMP and FDA regulations.

Connaissances

DOE & stats

Process capability

CAD software

Interpersonal skills

Self-motivated

Formation

Bachelor in Engineering

Outils

CAD software

Description du poste

Quasar Medical in Singapore seeks an experienced Automation Engineer to improve, streamline and automate manufacturing and related processes, reducing human intervention and maximizing efficiency. You will support Balloon Catheter, Extrusion, Braid and Shaft Coil lines in Singapore and advance manufacturing methods across Quasar Singapore.

Responsibilities include setting up automated processes, standardizing tooling and fixtures, qualifying processes, and ensuring compliance with GMP, ISO13485