PURPOSE OF JOB

Collaborate with the Production Department to identify improvement opportunities in the process and implement them. Collaborate with the transfer of products to manufacture and ensure a high degree of process capability. Validate process changes with documentation and necessary approvals.

Supervise process technicians and is responsible to support the production lines.

JOB OPERATION/ELEMENTS

Responsibilities

· 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 techinicians.

REQUIREMENTS

EDUCATION:

· Bachelor in Engineering or Manufacturing

· Bilingual: English and Spanish

EXPERIENCE:

· Minimum 3-5 years in an industrial/manufacturing industry, preferable medical device manufacturing environment. Experience with GMP and ISO 13485 a plus

ADDITIONAL SKILLS:

· Project planning and execution.

· Excellent communication skills including written and verbal reporting.

· Experience working with Catheters and Guide wires preferred.

· Lean Six Sigma experience a plus.

· Must be a self-starter, able to work with no supervision.

· Must be proficient in counting and math.

· Able to work effectively in a team.

· Good communication skills.

· Computer skills.

· Be a champion to improve productivity.