Manufacturing Engineer ETO Sterilization

Flexible & Integrated Technical Services, LLCVillalba, PR

About The Position

For Engineering services in the Manufacturing area. Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece?

Requirements

  • Bachelor’s Degree in Engineering
  • three (3) years of exposure within the Medical Devices Industry
  • Bilingual: Spanish and English
  • Excellent teamwork skills
  • Experience in Change control of medical devices.
  • Experience in Equipment commissioning/qualification.
  • Experience with ETO, steam, liquid chemical, and radiation sterilization.
  • Experience in non-sterile and pharmaceutical package design.

Responsibilities

  • Designs manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material.
  • Designs the arrangement of machines within plant facilities to ensure the most efficient and productive layout.
  • Designs the sequence of operations and specifies procedures for the fabrication of tools and equipment, as well as other functions that affect product performance.
  • Adapts machine or equipment design to factory and production conditions.
  • May incorporate inspection and test requirements into the production plan.
  • Inspects the performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action for problems.
  • Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques.
  • Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
  • Ensures processes and procedures comply with regulations.
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