PURPOSE OF JOB Collaborate with the Production Department to identify troubleshooting in the process.
Update documentation such as DMs, DHRs, etc.
Collaborate with the transfer of products to manufacture.
Validate the changes in processes.
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's degree in Engineering or Manufacturing.
EXPERIENCE : Minimum of 6 months of proven experience in a manufacturing or engineering role within a medical device manufacturing environment ( required ).
PREFERRED QUALIFICATIONS : Experience with GMP and ISO 13485 a plus.
Lean Six Sigma experience a plus.
POSITION SKILLS : Professional fluency in English is required (C1), both written and oral.
Good communication skills including written and verbal reporting.
Must be a self-starter, able to work with minimal supervision.
Able to work effectively in a team.
Computer skills.
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