Molding Engineer, Process

Masimo; Pasir Gudang; On-site; MYR 60,000 - 80,000; Full time

Job summary

A leading technology firm is seeking an experienced Engineer, Molding to coordinate molding processes in manufacturing. The role involves ensuring machine efficiency, providing engineering support, and maintaining compliance with regulatory standards. Ideal candidates should have at least 5 years of experience in automation and control systems, along with strong problem-solving skills. This position is based in Pasir Gudang, Malaysia.

Qualifications

• At least 5 years of experience in machine automation and control system.
• Knowledge of scientific molding approach methodology.
• Strong in statistical analysis and good interpersonal skills.

Responsibilities

• Coordinate molding processes used in manufacturing.
• Ensure minimum machine downtime and compliance with regulations.
• Provide coaching and training to technicians.

Skills

Machine automation and control system

Statistical analysis

Problem solving

Technical documentation

Interpersonal skills

Education

High School and Technical, Bachelor or Partial College

Tools

MS Word

Excel

PowerPoint

Job description

Job Summary

The Engineer, Molding is responsible to coordinate molding processes used in manufacturing.

Duties & Responsibilities

• Ensure Molding production equipment and machinery in the plant achieves minimum machine downtime and obtains minimum NCR.
• Provide engineering support to Production, Engineering and QC in terms of process improvement, repairs, troubleshooting of automation and control system, calibration and process validation.
• To carry out the change request and evaluate the change effects on validated process.
• Participate in cost reduction, cost saving, carrier set-up and carrier spare parts. Improve efficiency of carrier maintenance time.
• To investigate the process and quality failure resulting from equipment/process related problems and provide permanent solution to fix them.
• Provide coaching and training to technicians on the carrier service and repair activities.
• Motivate and cultivate positive mindset and ethical among engineering associates and optimize individual performance to the company.
• To out-source and evaluate new technological innovations which lead to an increase of machines efficiency and product quality.
• Design and write engineering study protocol and execute the protocols which include data collection, analysis and provide recommendation if further improvement is required.
• Design and write URS and FDS technical documents for Molding production equipment.
• Ensure all maintenance SOPs and documentation are in compliance with OSHA, ISO 13485, GxP and US regulations.
• Ensure updated release documents are changed, reviewed and approved before implementation of validation and its must remain and operate in validated state.
• Ensure all the maintenance records are properly managed.
• Promote effective communication with associates across all shifts and ensure efficient shift hand-over and effective start-up meetings.
• Adherence to Masimo Values & Behaviors, observe and ensure full compliance with Masimo Code of Business Conducts.
• Observe and ensure full compliance with Masimo Health Safety and Environment Standards

Minimum Qualifications

• At least 5 years of experience in machine automation and control system, equipment installation, start-up, operation, maintenance, calibration and process engineering for high volume of food industries, electronics/electrical industries, high precision plastic molding industries, medical devices or pharmaceutical industries. Preferred
• Level: Ideally in pharmaceutical/medical device regulated environment

Preferred Qualifications

• Knowledge of scientific molding approach methodology
• Knowledge of peripheral equipment such as: material dryers, mold temperature controllers, sprue pickers, servo robots, etc.
• Knowledge of injection molding machines
• Knowledge on mold setup
• Metrology including GD&T(desired)
• Use of measuring equipment (Calipers, micrometers, etc.)
• Strong computer skills in MS Words, Excel spreadsheets, PowerPoint presentation
• QMS and GMP knowledge and skill in ISO 13485, US FDA part 820 experience
• Strong in statistical analysis and good interpersonal skills
• Good skills in PLC and PC based equipment/machine
• Good problem solving and decision-making skills
• Equipment Repairs Budgetary
• Critical Equipment Uptime/Downtime
• Achieve key new product development milestones are delivered on time
• Excellent trouble shooting skill
• Able to conduct Validation and Re Evaluations

Education

High School and Technical, Bachelor or Partial College desired

Physical requirements/Work Environment

This Position works alternate between office position and production floor. It requires frequent sitting, standing and walking. Requires the use of a computer, digital equipment, etc. May stand for extended periods of time when performing a process validation, might require traveling, the ability to operate a motor vehicle and maintain a valid Driver’s license is required.