Manufacturing Engineer - Billerica, United States - FirstPRO

Description

firstPRO is now accepting resumes for a

Manufacturing Engineer Ill

on-sitein their

Billerica, MA

facility.

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
Work with the Manufacturing Engineers and direct technicians to assist in troubleshooting and maintaining the manufacturing process equipment.

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).

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.

Qualifications
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.
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.
by Jobble

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