Extrusion Engineer (Catheter / Tubing) - North

Our client is a well-established MNC specializing in the manufacturing of advanced medical devices for global healthcare customers. Due to their ongoing business expansion, they are looking for an Extrusion Engineer to join their growing engineering team. They are located in the (North) – easily accessible.

Responsibilities:

• Develop, optimize, and validate extrusion manufacturing processes to support new product introduction, engineering changes, and continuous production improvements.
• Conduct process validation activities, including IQ/OQ/PQ, equipment qualification, material validation, FMEA, TMV, and manufacturing validation protocols.
• Investigate manufacturing issues, perform root cause analysis, implement corrective actions, and improve process capability, yield, and production efficiency.
• Design, develop, and improve tooling, fixtures, work instructions, and manufacturing methods to enhance productivity and product quality.
• Monitor manufacturing performance through process audits, statistical analysis, DOE, SPC, and capability studies while ensuring compliance with quality standards.
• Support production planning by evaluating manufacturing capacity, labour utilization, material consumption, and equipment requirements.
• Prepare technical documentation, engineering reports, validation records, and process improvement recommendations.
• Evaluate and implement new manufacturing technologies, equipment, and process improvements to improve operational performance and cost efficiency.
• Ensure compliance with ISO 13485, GMP, FDA regulatory requirements, and company health, safety, and quality management systems.

Requirements:

• Bachelor's Degree in Engineering or a related technical discipline.
• 2–5 years of manufacturing engineering experience in a high-volume manufacturing environment; medical device or catheter extrusion experience is advantageous.
• Hands-on experience in process validation, equipment qualification, and manufacturing process improvement.
• Proficient in DOE, SPC, process capability analysis, and validation documentation (e.g. FMEA, IQ/OQ/PQ, TMV).
• Familiar with FDA, GMP, ISO 9001, and ISO 13485 standards; LEAN or Six Sigma certification is an added advantage.

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/CV.

We regret that only shortlisted candidates will be notified.

Email Address: [email protected]
EA License No: 19C9682
EA Personnel No: R22104769
EA Personnel Name: Ong Boon Kiet (Travys)