• Core Products Engineer

    Posting Date 1 month ago(5/7/2018 11:39 AM)
    Requisition ID
    Job Location(s)
    West Lafayette IN United States
    Position Type
    Full Time
    Cook Biotech Inc.
  • Overview

    The Core Products Engineer at Cook Biotech, Inc. has responsibility for participating in continuous process improvement and quality related to the design and/or manufacturing of core products. This may include design control, process improvement, process validation and other related duties as determined by the CBI Quality System.



    • Improve design and manufacturing quality by completing projects that improve processes and/or design by error-proofing, address root cause, eliminate non-value add activities, identify and appropriately elevate process constraints
    • Learn to effectively use continuous improvement tools (e.g. 5S, value stream mapping, theory of constraints, kaizen) to improve design and manufacturing quality
    • Relentlessly eliminate waste from processes by evolving the CBI quality system
    • Assist in seeking out, leading, developing and implementing advanced manufacturing solutions as agreed upon by key stakeholders
    • Conduct FMECA risk analyses for Core Products as needed to support Regulatory or other quality system activities

    • Conduct process validations and re-validations in a timely manner and according to quality system requirements
    • Ensure process validations for Core Products are consistently relevant, appropriately implemented and documented
    • Select, qualify and improve production equipment, tools and instruments with the goal of preventing defects, designing for manufacturability and improving quality
    • Write specifications and instructions
    • Coordinate and/or provide training on process improvements to production personnel
    • Remain current and apply the understanding of FDA-ISO 13485 and quality system requirements in carrying out duties


    • Bachelor's degree in Engineering or related field
    • Able to work independently
    • Good project management skills to work on multiple projects simultaneously
    • Able to work in interdepartmental teams
    • Able to effectively listen to ideas and concerns coming from Production personnel
    • Able to effectively communicate ideas, especially to Production personnel

    • Good record keeping and documentation skills
    • Good communication skills
    • Willing to work with material derived from animal tissues
    • Sufficient background to generally understand medical and biotechnology terminology
    • Ability to make prototypes and conduct bench tests


    Physical Requirements:

    • Must be able to perform the essential functions of the job, with or without reasonable accommodations
    • Limited exposure to hazardous chemicals used in the manufacture of the product

    • Physical demands are typical of an office and classroom environment.


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