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Billerica

    Senior Manufacturing Engineer - Billerica, United States - FirstPRO

    FirstPRO
    FirstPRO Billerica, United States

    1 week ago

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    Human Resources
    Description

    FirstPro is now accepting resumes for a Senior Manufacturing Engineer position based in Waltham, MA. This role will focus on providing support for manufacturing operations focusing around Test Strip manufacturing. You will work on leading development, designing and validating existing equipment and processes. This is a permanent, direct-hire role that can offer benefits.

    Responsibilities

    • 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
    • Participation in design reviews on new products during development phase.
    • 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).
    • 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.
    • Create new manufacturing documentation and updating/enhancing existing documentation which conform to Quality System Regulations (QSR's) ISO Standards.
    • Train and or oversee the training of employees on new products, equipment, and processes.

    Requirements

    • 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.
    • 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.
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