Job Description

Company Background:

A global medical technology company specializing in innovative noninvasive monitoring solutions and advanced healthcare technologies. The organization is committed to improving patient outcomes and reducing the cost of care by developing cutting-edge devices and systems used in hospitals, clinics, and homecare settings. With operations in Malaysia, it supports engineering, manufacturing, and R&D activities, adhering strictly to international standards. 

This role requires candidate to plan, coordinate, direct, execute and document activities related to extrusion process design and control. Candidate must have a strong extrusion background and be proficient in tooling theory, tooling design, processing techniques and process development for a continuous run extrusion process. Candidate will be responsible to establish and maintain process control and work on process improvement activities.

Duties & Responsibilities:

• Works with equipment suppliers to optimize machine operating sequence and man machine interface
• Defines critical product and process variables, validates variable set points and impact of deviations via DOEs.
• Develops Process FMEA and uses analysis to determine necessary improvements and controls to insure process and product reliability.
• Develops, manages and controls manufacturing process recipes. Creates technical documents defining the process capabilities and limitations.
• Executes routine process and product validation testing to include documentation of technical protocols and results.
• Responsible for establishing / maintaining measurement systems for process capability, process quality, process first run yield, process material yield etc.
• Responsible for developing process improvement plans to address manufacturing yield issues, quality issues or as part of continuous process improvement.
• Responsible for development & research, testing and validation of improved manufacturing methods.
• Acts as resident expert for extrusion, in process measurement equipment, automated material conveyance equipment, etc.
• Hires, trains and develops process techs for critical process support.
• Basic knowledge of equipment, equipment troubleshooting and maintenance.
• Identifies plans, executes and communicates results for process improvement projects that improve business performance in the form of material yields, machine efficiencies and operational costs.
• Leads in the development of a disciplined operational culture that is required in a high manufacturing complexity, high material cost and zero defect environment.
• Takes an active role in supporting business unit objectives.

Job Requirements:

Compulsory:

• Experience with plastics manufacturing extrusion or injection or similar.
• Experience in modern manufacturing principles and techniques
• Working knowledge of statistical techniques (e.g., DOE, SPC)
• Experience in process automation, verification and validation
• Good communication skills and technical writing abilities
• Good conceptual, analytical, and problem-solving abilities
• Good computer skills Solidworks (CSWA), Microsoft Office suites etc.
• Ability to be work effectively in cross-functional teams
  

Preferred & Advantages:

• Bachelors degree required on mechanical, electrical or related engineering.
• 5+ years of demonstrated process related work history in a plastics extrusion environment.
• Knowledge of polymer material properties and processing techniques.
• Proficiency in developing designs of experiments and analyzing outcomes using statistical tools (such as Minitab).
• Working knowledge of CAD software (Solidworks, Autocad), mechanical simulations and modeling a plus.
• Working knowledge of Microsoft Office Suite.
• Working knowledge of AC vector drives, servo motor controls, electromagnetic braking devices providing multi-device speed coordination and tension control a plus.
• Knowledge and experience in ISO13485 and preferably FDA QSR requirements.
• Knowledge of Process Validation activity.
• Knowledge on developing and executing cost reduction/saving projects thought lean manufacturing techniques.
• Good English communication skills, both verbal and written, and the ability to effectively interface with Research and Development, Quality Assurance, and other functional groups in the organization.
• Hands-on skills with electro-mechanical troubleshooting and diagnostics.
• Excellent technical writing abilities.
• Experience in application of statistical process controls in a manufacturing environment.

Salary Range: RM4k - RM8k