Senior Manufacturing Process Engineer - Medical Devices

QUASAR MEDICAL (SINGAPORE) PTE. LTD.; Singapore; On-site; SGD 90,000 - 120,000; Full time

Job summary

QUASAR MEDICAL (SINGAPORE) PTE. LTD. is seeking an experienced process engineer to manage new product introductions, process engineering, and sustaining activities in Singapore.

You will study product and manufacturing methods to develop and improve processes across Quasar Singapore, act as a senior team member, and mentor junior engineers. The role involves leading cross-functional teams, developing qualifications and validations, and ensuring GMP/ISO13485 compliance while driving cost and

Qualifications

• Bachelor in Engineering or similar technical field with 5–8 years’ experience in high-volume production.
• Medical Device Manufacturing experience preferred, especially catheter production techniques.
• Proficient in DOE and statistical techniques (SPC).
• Knowledgeable in defining process capabilities and control charting.
• Experience writing protocols for validations and qualifications including FMEA, IQ/OQ & TMV.

Responsibilities

• Evaluate and improve manufacturing processes through research, product design, and collaboration with vendors and operators.
• Design and develop processes for new products, changes, and enhancements, including tooling and fixtures.
• Troubleshoot processes, refine throughput, and design fixtures and assembly techniques.
• Improve efficiency by analyzing workflow, space, and equipment layout.
• Process qualifications and validations including equipment qualifications and material specifications.
• Lead process qualifications and validations, including equipment and material specifications.
• Ensure product and process quality through testing and establishing standards.
• Provide decision-making information by calculating costs and reviewing schedules.
• Prepare reports by analyzing and summarizing trends.
• Maintain equipment by coordinating maintenance and repairs.
• Ensure Health & Safety, including accident investigation and corrective action.

Skills

Interpersonal communication

DOE & SPC

Documentation & records

Change management

Self-motivation

Education

Bachelor in Engineering or related field

Tools

CAD software

Job description

QUASAR MEDICAL (SINGAPORE) PTE. LTD. is seeking an experienced process engineer to manage new product introductions, process engineering, and sustaining activities in Singapore.

You will study product and manufacturing methods to develop and improve processes across Quasar Singapore, act as a senior team member, and mentor junior engineers. The role involves leading cross-functional teams, developing qualifications and validations, and ensuring GMP/ISO13485 compliance while driving cost and