Quality Engineering Intern

LivaNova•Arvada, CO

About The Position

The Quality Engineering Intern will assist Quality Engineering in completing a material/substance database by collecting and analyzing data for the evaluation of materials used in LivaNova products. The intern may also help update procedures as part of process improvements and ongoing maintenance of the Quality Management System. The intern will support quality engineering activities related to product design and manufacture, in compliance with Quality Management System requirements and the regulations of countries where the franchise distributes and sells products. Projects will include conformance with medical device requirements under ISO 13485 and FDA 21 CFR Part 11.

Requirements

  • Currently pursuing a Bachelor's degree in Biomedical, Chemical, or Mechanical Engineering, or another technical degree such as computer science, chemistry, or biochemistry.
  • Must have completed junior year.
  • Minimum GPA of 3.0.
  • Demonstrated in-depth or broad engineering skills.
  • Proficiency with quality tools such as flowcharts, statistical data analysis, and mathematical reasoning.
  • Ability to work in a changing environment and with personnel at all levels, using constructive confrontation.
  • Ability to analyze and solve problems.
  • Excellent written and verbal communication and presentation skills, including the ability to communicate across functional lines.
  • Able to comprehend oral and written information.
  • Able to work in a clean room environment and tolerate chemical odors.
  • Able to work in a laboratory environment and tolerate the smell and sight of blood.
  • Able to perform repetitive computer work.

Responsibilities

  • Support Quality Engineering activities related to product design and manufacture in accordance with Quality Management System requirements and applicable regulations.
  • Work on projects related to conformance with ISO 13485 and FDA 21 CFR Part 11 medical device requirements.
  • Review supplier-provided material information and enter it into the material database.
  • Contact suppliers when additional information is needed.
  • Communicate issues or information needs to Quality Engineering.
  • Assist with procedure updates related to process improvements and ongoing Quality Management System maintenance.
  • Respect applicable Health and Safety Regulations.
  • Perform other duties as required by the manager.
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