R&D Process Engineer

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Company Name :IBA Infotech LLC

Type : Contract

Primary Skills : Brooklyn Park

Location : DOE


Job Description:


  • Creates and improves processes pertaining to:
    • Feasibility Builds, Manufacturing, and Inspection
    • Planning and executing process characterization activities, through tools i.e. design experiments
    • Equipment selection
    • Process development and documentation
    • Component validation and verification samples and testing
    • Develops and executes IQ, OQ and PQ protocols and reports
    • Operator training
    • Process Failure Mode Effects Analysis
    • Clinical Builds
    • Process Validation
    • Assembly and Component Process flow layouts
  • Involved with manufacturing and product design teams to:
    • Facilitate and create processes
    • Implement systems to produce a quality and cost effective product
    • Improve Labor cycle times
  • Improve existing processes for boosting productivity, quality and cost
  • Assist with the preparation of proposals and quotes for customers
  • Creates process risk assessments
  • Assesses safety requirements ensuring they are part of the process for the builder, user and customer
  • Prepares Engineering Change Orders for processes, components, and Bill of materials
  • Performs and advises Corrective and Preventive Action tasks
  • Other Duties as assigned


  • FDA cGMP principles and practices
  • Must have 3 or more years’ experience of medical device process or manufacturing engineering
  • 2 years’ experience with bonding techniques. I.E. - Adhesives, Chemical, Laser, Resistance welding
  • Familiarity with biocompatible materials
  • Exposure to Pro-E / CREO and or SolidWorks preferred
  • Strong computer skills associated with Microsoft software
  • Demonstrated ability to interpret technical drawing, blueprints, specification and illustrations
  • Possess a keen attention to detail
  • Must be able to read, write and speak fluent English
  • Excellent reading, writing, communication, and organizational skills
  • Demonstrated ability for systematic problem solving, DMAIC
  • Maintains performance with changing priorities under minimal supervision
  • Must maintain high ethical standards
  • Must be able to make clear and accurate decisions
  • Ability to learn and apply new technology
  • Must have a BS degree in relevant engineering discipline with a minimum 3 years of related engineering experience