Responsibilities 

• Support Production area in troubleshooting process.
• Respond to the occurrence of defects and unplanned production downtimes due to equipment failures, process issue, etc., to reestablish production.
• Collaborate with the production team to investigate the root causes of process problems and implement corrective actions.
• 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.
• Attend daily shift meetings and communicate by providing updates with various departments.
• Perform nonconformance and corrective actions investigations.
• 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 estimate production times, 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.
• Propose new technology developments and ideas to enhance quality, safety, customer satisfaction, production standards, and cost efficiencies.
•  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.

REQUIREMENTS

EDUCATION:  

• Bachelor in Engineering or Manufacturing 
• Bilingual: English and Spanish

EXPERIENCE:

• Minimum 6 months in an industrial/manufacturing industry, preferable medical device manufacturing environment. Experience with GMP and ISO 13485 a plus.

ADDITIONAL SKILLS:

• Good communication skills including written and verbal reporting.
• Lean Six Sigma experience a plus.

• Must be a self-starter, able to work with minimal supervision.
• Able to work effectively in a team.
• Good communication skills.
• Computer skills.