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