Manufacturing Engineer II

Primary Role:

Designs and prepares drawings, and recommendations for approval for; manufacturing process automation and individual components for reagent manufacturing to improve the manufacturability.

 

Job Responsibilities


Primary Responsibilities:  

  • Supports the Manufacturing group in the development of automated reagent mfg processes and or equipment
  • Provides design and/or direction on assembly and filling of plastic assemblies
  • Interacts frequently with scientist and other research personnel to determing project requiremens, goals, schedules and cost targets.  Applies knowledge of scientific principles to translate life science processes into engineering objectives.  Uses verbal and written communication to create and maintain a design history project.
  • Performs technical activities leading to innovative applications and extensions of existing or new products, processes or technologies which are of major importance to a project.  Presents and publishes work internally and externally where appropriate.
  • Uses methods and facilities that are supplied, recommended and/or required by IXI, maintains and organized and database of all analysis and design output, including but not limited to 3D model, assembly and drawing files, test plans and reports, research records of components, materials and processes, and transcripts of oral and written communicaitons with suppliers, consultants and collaborators
  • Analyze and solves complex problems using creative and effective techniques or processes
  • Performs product and process verification test plans with expected results to match CRD
  • Performs process and product verification tests for reliability, robustness and stability
  • Fully comprehends engineering principles, theories, concepts, practices, and techniques. Continue to develop expertise in areas of specialiation
  • Utilizes knowledge of business goals and broad understanding of industry activities and technologies to complete tasks. Develops a working knowledge of internal functions
  • Exercises judgement in selecting innovative, practical methods to achieve problem resolution
  • Frequest intra- and inter- organization and external customer contacts
  • Works only under very general direction.  Participates in determining objectives of assignments. Independently plans work and develops approach to solutions.  Receives technical guidance as necessary
  • Interface to R&D during the feasability, development and transfer to commercial phases of the PDP

Secondary Responsibilities:  

  • Participates on product or project core teams as required
  • Maintains and enhances technical knowledge on company product lines through attendance and participation at in-house training programs, as well as self-study by reading trade journals, manuals and books
  • Provide support for operational supplies for the manufacturing area
  • Perform additional duties as assigned

Required Interactions:  

  • Distribution
  • QC
  • Process Development
  • Product Development
  • Document Control
  • QA

 

Skills, Knowledge and Abilities (SKAs)


Job Skills:  

  • Ability to follow written and verbal instructions
  • Train within a reasonable timefram as determined by management
  • Demonstrated attention to detail
  • Ability to effectively communicate to line supervisor on production activities
  • Ability to focus and perform repetitive task with consistent outcome
  • Good documentation skills (per ISO 9001)
  • Support continuous improvement
  • Lite computer use
  • Ablitiy to work in a fast paced environment

Job Knowledge:  

  • Automated dispensing and kitting equipment
  • Reagent manufacturing
  • Inventory controls
  • Maintains records
  • Familiar with controlled environment room protocols and to comply with good manufacturing practices and standard operating procedures
  • Related hands on experience in a reagent manufacturing
  • ISO 9001

Additional Job Abilities:  

  • Demonstrated ability to perform independently and as part of a team
  • Ability to communicate in a clear, concise, personable manner
  • Lead an assemly line operation
  • Familiar with ERP, and PLM system
  • Use of microscope
  • Follow safety guidelines
  • Track materials, reconcilliation of work orders

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