Client is hiring a Manufacturing Engineer Ill on the second shift (3:00 PM - 11:00 PM. As the Manufacturing Engineer III you will provide technical support for all Test Strip Manufacturing operations regarding various processes and assembly issues. You will contribute to or lead development, design and the validation of existing and start up manufacturing equipment or processes as well as work with Advanced Manufacturing providing concurrent engineering and process for development for smooth transfer of new products/processes into manufacturing.
Other Responsibilities include:
Writing and updating the support documentation (APs, TPs, and OIs) for the process, developing, writing and performing IQ, OQ and VQs used in the manufacturing of Test Strips
Performing engineering studies and analyses on existing manufacturing processes to improve process reliability, problem solving, or improving product quality or cost.
Designing or purchasing tooling and equipment
Using appropriate statistical techniques to develop and complete process capability studies
Actively participating in other team activities to help ensure total team success
Taking an active role in learning for self and others to further company objectives
Technical Functions
Prioritize technical floor issues to resolve in a timely and efficient manner.
Design fixtures and necessary tooling for processes or modifications to equipment as needed. This includes researching and finalizing specifications for capital equipment as well as supplier quote comparison and ROI analysis.
Manage activities for continuous improvement to reduce product cost and cycle times.
Create new manufacturing documentation and updating/enhancing existing documentation which conform to Quality System Regulations (QSR's) ISO Standards.
Review and implementation of lean manufacturing techniques.
Investigation of returned items from the field to determine root cause and implementing corrective/preventative actions to prevent reoccurrence.
Qualifications/Skills and Competencies:
Must be proficient with Microsoft Office, (Solidworks and/or AutoCAD programs.
Must have strong written and oral communication skills.
Knowledge of FDA QSR's and ISO regulations is helpful.
Education/Experience:
B.S in Mechanical Engineering / Biomedical / Electromechanical Engineering with 5-10 years of experience in the High Volume manufacturing field (ideally biomedical related)
Must have experience maintaining and troubleshooting complex high volume automated manufacturing equipment.
Experience with vision inspection systems, electronics, pneumatics and machine control systems a plus.