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Molding Engineer, Process

Molding Engineer, Process

Masimo CorporationMalaysia, Malaysia
30+ hari lalu
Penerangan pekerjaan

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 & Preferred Qualifications and Experience

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.)
  • 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
  • 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 validDriver’s license is required.

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