Manufacturing Engineer II

El Coyol Free Zone, Alajuela. 

Hybryd positon

This is an opportunity to make a direct impact on manufacturing performance, work with cross-functional teams, contribute to innovative engineering projects, and help drive continuous improvement in a highly technical manufacturing environment.

• Support Production area in troubleshooting process and deliver timely solutions for product development.


• Respond quickly to the occurrence of defects and unplanned production downtimes due to equipment failures, process issues. Solve related problems to resume production.


• Collaborate with the production team to investigate the root causes of process problems and implement corrective actions. Develop procedures to ensure product quality / process capability and reduce process variability ensuring consistency in Mfg. execution.


• Review procedures to ensure accuracy and upgrades required by change orders in the Documentation. Working with Production to develop production processes, standard operating procedures and drawings.


• Support the implementation of GMP (Good Manufacturing Practices) throughout the production organization. Participate in the training of production supervisors, operators and assemblers. Provide advice and technical processes in both new and existing resources.


• Attend daily shift meetings and communicate by providing updates with various departments.


• Perform nonconformance and corrective actions investigation from root cause all the way to effectiveness


• Responsible for creating, routing and execution of all engineering reports, including all the validation phases as of engineering studies, process development, installation, operational and performance qualifications.


• Define and deploy manufacturing work instructions, procedures and standard work.


• Develop work center layouts, estimate production times, staffing requirements, capacity analysis/model and related costs.


• Facilitate ease of manufacturing to produce quality, cost effective products with optimized yields.


• Apply Lean Manufacturing, Six Sigma and OpEx back to basics principles while improving sustaining operations and executing CI initiates. 


• Evaluate existing product flow, investigate and identify new technology developments including automation based solutions, and other technical improvements to drive process improvements to enhance quality, safety, customer satisfaction, production standards, and cost efficiencies


• Determine parts and tools needed, and its controls in order to achieve manufacturing goals and reduce costs.


• Collaborate with the development and transfer of products. Manage the installation and proper performance of new processes and equipment.


• Conduct verification and validation of new processes and modifications to ensure process capability.


• Define priorities for the process technicians.


• Review, keep track, and define plans to improve down times related to tipping processes.


• Responsible for process technicians training within QCBD.


• Report on a weekly basis the working hours for the process technicians.
  
  
  
  

Education

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  Bachelor's degree in Engineering, Manufacturing Engineering, or a related field.

  
  


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  Bilingual proficiency in English and Spanish.

  
  

Experience & Technical Skills

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  3–5 years of experience in an industrial or manufacturing environment.

  
  


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  Experience in medical device manufacturing is highly preferred.

  
  


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  Knowledge of Good Manufacturing Practices (GMP) and ISO 13485 standards is a plus.

  
  


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  Experience with process development, troubleshooting, validation, and continuous improvement methodologies.

  
  


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  Familiarity with Lean Manufacturing and Six Sigma principles.

  
  


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  Experience leading, mentoring, or coordinating technical teams is desirable.