Manufacturing Engineer Ill on-sitein our Billerica, MA facility. The Manufacturing Engineer III will provide technical support for all Test Strip Manufacturing operations regarding various processes and assembly issues. The Manufacturing Engineer III will contribute to or lead development, design and the validation of existing and start up manufacturing equipment or processes. This person will 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
More specific responsibilities will include:
Floor Support
Main responsibility is to provide technical support for all the manufacturing process equipment.
Responsible for writing and updating the support documentation for the process
Work with the Manufacturing Engineers and direct technicians to assist in troubleshooting and maintaining the manufacturing process equipment.
Prototype Build
Participation in design reviews on new products during development phase.
Pilot & Production Build
Manage technical resources consisting of engineers/technicians in the transfer of new processes and assemblies to manufacturing as well as providing cost estimates, creating work breakdown structures, creating/maintaining project schedules, providing project status reports, presentations of concerns/accomplishments to team and upper management.
Manage the various functions of projects for proper implementation that meets all regulatory guidelines including the creation and performance of Installation, Operational & Performance Qualifications, Process Validations and Failure Mode Effects Analysis (FMEA).
Technical FunctionsPrioritize 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.
Training
Train and or oversee the training of employees on new products, equipment, and processes.
Document training records.
Demonstrate the use of the equipment to visitors.
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 Biomedical or High Volume manufacturing field.
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.