PROCESS ENGINEER

Sem Matic Sdn Bhd; Johor Bahru; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading manufacturing company in Johor Bahru is seeking a qualified candidate to develop and optimize plastic injection molding processes for medical devices. The ideal candidate will have a Bachelor's Degree in Chemical Engineering or Manufacturing, with at least 3 years of relevant experience. The role involves ensuring compliance with ISO 13485 and FDA regulations, leading validation activities, and collaborating with cross-functional teams. Strong troubleshooting skills and knowledge of statistical process control are essential.

Qualifications

• Candidate must possess at least Bachelor's Degree in Chemical Engineering or Manufacturing.
• At least 3 years of working experience in the related field.
• Knowledge of ISO 13485 and other quality standards is essential.

Responsibilities

• Develop, validate, and optimize plastic injection molding processes.
• Lead IQ/OQ/PQ activities ensuring compliance with regulations.
• Collaborate on new mold development and modifications.
• Identify and resolve molding issues through analytical tools.
• Implement and monitor SPC to maintain process control.

Skills

Process Analysis

Regulatory Compliance

Troubleshooting

Statistical Process Control (SPC)

Cross-functional Collaboration

Education

Bachelor's Degree in Chemical Engineering/Manufacturing

Job description

Responsibilities

• Develop, validate, and optimize plastic injection molding processes for medical device components.

2. Validation & Regulatory Compliance

• Lead IQ/OQ/PQ (Installation Qualification, Operational Qualification, Performance Qualification) activities.
• Ensure all molding processes comply with ISO 13485, FDA regulations, and customer-specific quality requirements.
• Prepare and maintain validation protocols, reports, and change control documentation.

3. Tooling & Equipment Support

• Collaborate with toolmakers and design engineers on new mold development and modifications.
• Support mold trials and sampling to evaluate tool performance.

4. Defect Analysis & Troubleshooting

• Identify and resolve molding issues such as flash, short shots, sink marks, voids, and contamination.
• Analysis tools like 5 Whys, Fishbone Diagrams, and FMEA to drive corrective actions.

5. Documentation & Process Control

• Implement and monitor SPC (Statistical Process Control) to maintain process control and minimize variation.

6. Cross-functional Collaboration

• Work closely with R&D, Quality Assurance, Production, and Regulatory Affairs during new product introduction (NPI).
• Train operators and technicians on molding procedures, process changes, and cleanroom practices.
• Lead or participate in Lean Manufacturing, Kaizen, or Six Sigma projects.
• Analyze process capability and drive initiatives to improve yield, reduce cycle time, and minimize scrap.

Qualification Requirement

• Candidate must possess at least Bachelor's Degree in Chemical Engineering/Manufacturing.
• At least 3 Year(s) of working experience in the related field.
• Knowledge of ISO 13485 and other quality standard as well as safety regulatory requirements.
• Familiar with Capability analysis reports.
• Capable to analyze or execute a CAPA report.