Molding Engineer, Process

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.)
• 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

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.