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    Manufacturing Engineer II - Salt Lake City, United States - bioMérieux SA

    bioMérieux SA
    bioMérieux SA Salt Lake City, United States

    4 weeks ago

    Default job background
    Description
    This engineer works on a cross-functional Manufacturing Engineering team to support several aspects of the consumable manufacturing process. Partners with internal team members and vendors to optimize manufacturing and product performance. Performs troubleshooting and routine maintenance of basic to moderate manual and automated manufacturing processes.

    Leverages experience and skillset to implement best practices with the realm of consumable medical device manufacturing by identifying root causes and recommending solutions.

    Contributes to the resolution of basic to moderate manufacturing engineering problems.
    Job Title

    Manufacturing Engineer II (Consumables – Biochemistry/Formulation)
    Direct Supervisor

    Manufacturing Engineering Manager
    Description of Responsibilities
    Job Summary

    This engineer works on a cross-functional Manufacturing Engineering team to support most aspects of the biochemical reagent, formulation, and consumable manufacturing process.

    Partners with internal team members and vendors to optimize product performance.
    Performs troubleshooting and routine maintenance of moderate to complex manual and automated manufacturing processes.

    Leverages experience and skillset to implement best practices with the realm of consumable medical device manufacturing by identifying root causes and recommending solutions.

    Contributes to the resolution of moderate to complex manufacturing engineering problems.
    Essential Job Duties and Responsibilities
    Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics' Quality System.
    Supports most aspects of biochemical reagent, formulation, and consumable product manufacturing process.
    Provides direction and oversight of junior engineers.
    Works with vendors to optimize product performance.
    Collects and analyzes data to determine performance of the product.
    Builds relationships both internally and externally as a member of a cross-functional team.
    Troubleshooting and routine maintenance of manufacturing equipment.
    Assisting with NCR investigations, write-ups, and product dispositions.
    Implements best practices and corrective actions.
    Identifying previously unknown process variables and implementing best practices.
    Performs FMEA to identify root causes of problems and present possible solutions.
    Contributes to solving moderate to complex manufacturing engineering and / biochemistry production problems.
    Makes design and technical decisions subject to review by Manufacturing Engineering Manager.
    Generates variety of technical documentation including WIDs, NCRs, technical reviews, studies, and executive summaries.
    Performs primary duties in a clean room environment.
    Develops and executes validation of new equipment and processes consistent with FDA standards.
    Performs other duties as assigned.

    Travel:
    some travel required.

    Team:
    usually works on a team with several technicians, engineers, and a project manager.

    Qualifications:
    Training and Education

    Minimum education and/or training requirements for this position (i.e. high school diploma, college degree, and/or certification).

    Preferred:
    M.S. or higher in Engineering or related discipline
    Experience
    Minimum time and type experience required for this position.

    5 years of experience in Engineering or related field including performance consistent with said experience, or 2 years of experience with a master's degree in engineering, Bioengineering, Chemistry, Life Science, or Equivalent.

    Knowledge, Skills and Abilities
    Knowledge, special skills and/or abilities required to perform the job functions (e.g., negotiation, technical writing; statistical evaluation).

    Skills:
    Manufacturing Engineering Support of Manufacturing, Reagent Production, Quality control, Process control, and Equipment:
    Trouble shooting and repair of production equipment and instrumentation.
    Technical writing
    Inspection
    Process validation
    Familiar with FDA standards
    Nucleic acid chemistry

    Experience with the following is preferred:
    GD&T
    Film and plastic bonding and sealing
    Solidworks
    Machining (esp. CNC)

    PLC
    Electrical Schematics

    Experience with the following is highly preferred:
    Trouble shooting and repair of reagent production equipment and instrumentation used in olgio synthesis and PCR chemistries. (liquid handling robots, H
    PLCs, GCMSs, oligo synthesizers, Lyophilizers, labelers, and tube and plate sealers etc.)
    Thermal characterization

    SPC
    Nucleic acid purification and characterization

    #J-18808-Ljbffr
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