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    Manufacturing Engineer 1 - Bloomington, United States - Cook Group

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    Description

    Overview:


    Responsible for providing technical support for the day-to-day production activities in the manufacture of custom, plastic components used in the assemblies of various medical devices.


    This is a hands-on position with visibility on the manufacturing floor and requires a high level of interaction with the production, product development, and quality teams.

    The engineer is responsible for supporting product development activities, continuous improvement, complaint resolution, CAPA investigations and other quality initiatives.


    Responsibilities:
    Supports production departments manufacturing issues with technical support as the process expert.


    Uses strong reasoning and problem-solving skills to investigate and analyze complex problems to determine root cause and implement innovative solutions to prevent recurrence.

    Supports and drives continuous improvement activities in the manufacturing department to improve operational performance.

    Leads technical aspect of process validation projects
    Assist product development teams with design for manufacturability requirements on new products.

    Supports new capital equipment and tooling purchases with appropriate documentation and evaluation
    Manages multiple technically oriented projects through coordinating internal and external resources.
    Collaborates on product complaint resolution.
    May be asked to perform other duties as required.


    Qualifications:

    D:
    Qualifications

    Minimally Required
    Identify those items that are minimally required to perform the essential duties of the role.
    Preferred/Specialized
    These are

    not

    required to perform the basic functions of the role
    Education
    Formal education (i.e. High School Diploma, Bachelors degree, formal certification)
    Bachelors degree in related field
    High School Diploma with applicable experience
    Bachelors degree in Engineering

    Experience
    Type or number of years directly related work experience
    No experience required with appropriate formal education.
    3+ years of work related to polymer processing
    Process validation (IQ, OQ, PQ)
    Equipment qualification (IQ, OQ, PQ)
    Knowledge
    Commonly known principles required for this field of work. For example, HVAC certifications, generally accepted accounting principles
    Fundamental understanding engineering principles
    Mechanical aptitude

    ISO 13485:2016

    CFR, FDA, OSHA, environmental regulations
    Skills
    Measurable learnings (i.e. can perform intermediate Excel and Word functions, advanced knowledge of research protocols)
    Proficiency at using Microsoft Office applications
    Troubleshooting and problem-solving skills
    Equipment / process troubleshooting
    Blue print reading
    Design of Experiments / 6 Sigma

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