Molding Engineer, Process

Job Summary

JOB DESCRIPTION

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

Minimum & Preferred Qualifications and Experience:

• 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.