• Product Life Cycle Engineer I

    Posting Date 7 months ago(5/30/2018 5:17 PM)
    Requisition ID
    2018-4613
    Job Location(s)
    West Lafayette IN United States
    Position Type
    Full Time
    Company
    Cook Biotech Inc.
    Category
    Engineering
  • Overview

    The Product Life Cycle Enginee I position at Cook Biotech, Inc. has responsibility for supporting products life cycle management to existing products and other related duties as determined by the CBI Quality System

     

    Responsibilities

    • Perform risk analysis updates with guidance from engineering, mentor or supervisor
    • Review complaints analysis and document effect on risk profile
    • Update risk management reports and conduct residual risk review
    • Perform Type-1 design changes as required
    • Conduct updates to design traceability matrix as per guidance from engineers and supervisor / mentor when required
    • Assist engineering in mitigating product life-cycle data deficiency

    • Conduct testing as needed
    • Work as a team member on individual and multi-member team projects
    • Communicate project status, hurdles to project lead or mentor/supervisor
    • Remain current and apply the understanding of FDA-ISO 13485 and quality system requirements in carrying out duties
    • Remain current and apply the understanding of ISO 14971

    Qualifications

    • Bachelor's degree in Engineering or related field
    • Good writing skills equivalent to medium level laboratory reporting
    • Able to work independently and on teams
    • Good task management skills and able to work on multiple tasks simultaneously
    • Able to effectively listen to ideas and concerns coming from experienced engineers and other CBI stake holders and incorporate suggestions appropriately

    • Able to effectively communicate task status to stake holders
    • Good record keeping and documentation skills
    • Willing to work on documentation and writing heavy tasks
    • Willing to work with material derived from animal tissues
    • Sufficient background to generally understand medical and biotechnology terminology
    • Ability to 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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