Senior Automation Engineer - Medical Device Manufacturing

QUASAR MEDICAL (SINGAPORE) PTE. LTD.

Singapore

On-site

SGD 90,000 - 130,000

Full time

8 days ago

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Job summary

Quasar Medical (Singapore) Pte. Ltd. seeks an experienced Automation Engineer to lead the design, development and deployment of automated manufacturing processes across Balloon Catheter and related lines in Singapore.

You will investigate new technologies, validate equipment, write IQ/OQ protocols, and ensure compliance with GMP, ISO13485, and regulatory requirements while driving cost-efficient continuous improvements.

Qualifications

Experience in high-volume production environments.
Experience with catheter production techniques preferred.
Proficient in DOE and statistics.
Knowledge of process validation and qualifications including IQ/OQ & MVP.

Responsibilities

Set up automation of manufacturing processes to govern production and delivery of products.
Streamline manufacturing to maximise productivity while maintaining quality and complying with internal and external regulations.
Design and create tools, jigs and fixtures for new lines, customers or products to improve automation and efficiency.
Identify opportunities for automation within manufacturing, document results, and develop new equipment or processes.
Write reports on new concepts, testing outcomes and ongoing efficiency improvements.
Troubleshoot automated processes or equipment when errors occur and refine processes for throughput.
Oversee process qualifications and validations including equipment qualifications and material specs.
Ensure Health & Safety within assigned areas, investigate accidents and drive corrective actions.
Investigate state-of-the-art process technologies for competitive advantage and cost-benefit.
Lead validation activities and maintain compliance with ISO13485, GMP and FDA regulations.