Manufacturing Engineer - Westbrook, United States - ICONMA

    ICONMA
    ICONMA Westbrook, United States

    2 weeks ago

    ICONMA background
    Description

    Manufacturing EngineerLocation:

    Westbrook, MEDescription: The position of Manufacturing Engineer is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine.

    In this role you will be responsible for supporting product development from concept through sustained manufacturing of FDA regulated products.

    Responsible for process development, equipment specification, acquisition and implementation.
    Works to identify root cause of manufacturing failures using structured problem solving. Applies root cause fixes to prevent reoccurrence.
    Evaluates machine logic, electromechanical systems and process controls to troubleshoot equipment.
    Completes design of experiments, validation, completion of testing and analysis of data for continuous improvement activities. Presents data to equipment teams.
    Suggests and supports new methods or materials for continual improvement of quality and efficiency.

    Analyzes current equipment for process suitability and provides detailed plans for improvementCreates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and procedures and other technical documents to ensure compliant, efficient and safe procedures.

    Initiates and works to resolve Quality Incidents and CAPA.


    Basic qualifications | education:
    Bachelor's degree (BS) in engineering or equivalent combination of education and experience.
    Minimum three years engineering experience in a manufacturing environmentFamiliarity with a variety of material testing and measuring methods.

    Knowledge of Database software; CAD software; Development software; Internet software; Inventory software; Manufacturing software; Project Management software; Microsoft Excel software and Microsoft Word software.


    Preferred qualifications:
    Experience working in a GMP, FDA, ISO and USDA regulated environment.
    Familiarity with cGMP and ISO 13485 regulations and practices.

    Familiarity with statistical analysis software (Minitab).As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

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