A leading global manufacturer of medical devices is seeking an experienced Extrusion Engineer to join our technical team. In this role, you will lead end-to-end catheter extrusion process developments, drive production yield improvements, execute equipment validation (IQ/OQ/PQ), and mentor technical staff within a regulated manufacturing environment.
Based in Perak.
the job.
- Process Setup & Tooling: Evaluate and select extrusion machinery, review mold/die designs, and establish stable processing parameters for production lines.
- Yield Improvement & Troubleshooting: Spearhead yield enhancement projects, resolve complex technical and quality issues, and document failure root-causes and preventive actions.
- Quality Standards & SOPs: Draft, refine, and maintain operational guidelines, quality acceptance benchmarks, and manufacturing work instructions.
- Material Qualification: Conduct trials, evaluate performance, and assess high-volume manufacturing feasibility for new resin materials, preparing comprehensive engineering reports.
- Validation & Compliance: Lead IQ, OQ, and PQ validation studies on machinery and processes to uphold medical quality system compliance.
- Technical Mentorship: Train operators and technicians on material behavior, equipment operation, processing fundamentals, and quality standards to build team capability.
- Preventive Maintenance: Design line maintenance schedules and oversee technicians during routine inspections, basic repairs, and parameter tracking.
- Engineering Documentation: Manage, archive, and update technical files, change requests, and validation dossiers.
the experience.
- Associate degree or higher in Polymer Materials, Material Forming, Mechanical Engineering, or related engineering discipline.
- Minimum 5 years of hands-on process development experience in the medical device extrusion industry, with strong knowledge of medical polymer properties and catheter/tubing extrusion processes.
- Technical Skills:
- Hands-on expertise in fine-tuning extrusion parameters and adjusting tooling/dies independently.
- Proven track record running equipment and process validations (IQ/OQ/PQ).
- Ability to interpret 2D/3D engineering drawings.
- Proficient in data-driven decision-making using tools like SPC and standard Quality Control methodologies.
- Systematic problem-solver with strong attention to detail, strong collaborative skills
