Extrusion & Manufacturing Process Engineer

Quasar Medical | Medical Device Manufacturer; Singapore; On-site; SGD 90,000 - 120,000; Full time

Job summary

Quasar Medical | Medical Device Manufacturer in Singapore seeks an experienced Process Engineer to lead manufacturing improvements for balloon catheter, extrusion, braid and shaft coil lines. You will develop, validate and transfer processes, design fixtures, and drive cost-effective solutions across high-volume production.

Candidates should have strong DOE/ SPC skills, CAD proficiency, and a track record in GMP/ISO13485 environments, with 5–8 years in medical device manufacturing.

Qualifications

• Bachelor in Engineering or similar technical field with 5–8 years’ experience in a high-volume production environment in the medical device sector.
• Experience with catheter production techniques is preferred.
• Proficient in DOE and SPC; knowledge of GMPs, ISO13485 and FDA.
• Strong documentation and record management; able to manage Engineering Change Orders.

Responsibilities

• Evaluates and improves manufacturing processes through design of research programs and collaboration with vendors and operators.
• Designs and develops manufacturing processes for new products and changes, including tooling and fixtures.
• Troubleshoots processes and refines to improve throughput; designs fixtures and assembly methods.
• Analyzes workflow, space needs and equipment layouts to boost efficiency.
• Conducts process qualifications and validations including equipment qualification and material specs.
• Documents and reports findings; computes production costs and estimates future requirements.
• Ensures health and safety within assigned areas and maintains compliance with EHS, GMP and ISO13485.

Skills

Interpersonal skills

DOE

SPC

Process capability

Control charts

Documentation

Engineering Change Order

Education

Bachelor in Engineering or equivalent technical field

Tools

CAD software

Job description

Quasar Medical | Medical Device Manufacturer in Singapore seeks an experienced Process Engineer to lead manufacturing improvements for balloon catheter, extrusion, braid and shaft coil lines. You will develop, validate and transfer processes, design fixtures, and drive cost-effective solutions across high-volume production.

Candidates should have strong DOE/ SPC skills, CAD proficiency, and a track record in GMP/ISO13485 environments, with 5–8 years in medical device manufacturing.