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. PreferredLevel : Ideally in pharmaceutical / medical device regulated environmentPreferred Qualifications :
Knowledge of scientific molding approach methodologyKnowledge of peripheral equipment such as : material dryers, mold temperature controllers, sprue pickers, servo robots, etc.Knowledge of injection molding machinesKnowledge on mold setupMetrology including GD&T(desired)Use of measuring equipment (Calipers, micrometers, etc.)QMS and GMP knowledge and skill in ISO 13485, US FDA part 820 experienceStrong in statistical analysis and good interpersonal skillsGood skills in PLC and PC based equipment / machineGood problem solving and decision-making skillsEquipment Repairs BudgetaryCritical Equipment Uptime / DowntimeAchieve key new product development milestones are delivered on timeAble to conduct Validation and Re EvaluationsEducation
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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