Krystle Swain

Usability Engineer — 15+ year industry experience — Now full time student

I am currently taking a step away from industry to complete my bachelors of science in mechanical engineering. I have spent over 15 year working in industry on a variety of projects, products and groups. I have vast experience with medical manufacturing, engineering design controls, verifications and validations. I am a very self-motivated team player with strong communication skills. I love to learn new technologies and skills to apply to my work and stay relevant in industry. I am looking for a chance to learn and grow with a new company during my summer availability. 

  Denver, CO, USA

 

Work Experience

Dec. 2019 - Feb. 2021

Usability Engineer  Terumo BCT

• Gathers customer data and design HF studies that satisfy company standards, supports research and development to produce user-friendly, innovative, products. 

• Maintains internal SOPs, performs human factors verification and validation studies and provides HF guidance across all company platforms. 

• My professional goal was to support the creation of products that are safe, effect and intuitive for user.

 Dec. 2006 - Jan. 2019

Engineering Technician II for Cell Processing  Terumo BCT

• Maintains a scientific lab of Quantum Cell Expansion Systems and an engineering lab for the department. 

• Troubleshoots and fixes devices, working closely with the metrology department to maintain the required calibrations of sensitive equipment. 

• As a supporting member of the Quality Team, I help with the investigation of in-house and in-field failures. I conceive, produce, and execute verification protocols/reports and validation protocols/reports. 

• Created other documentation per Terumo BCT engineering design controls, including but not limited to, risk management documentation.

Jan. 2004 - Dec. 2006

Systems Coordinator  Terumo BCT

• Maintains documentation and responsible for record retentions of clean room manufacturing line. 

• Responsible for training new associates and providing training of manufacturing changes to all associates.  Ensures that the flow line runs properly with no failures.

Education

CU

Mechanical Engineering

Apr 2010 - Present

Skills

User Experience + Technician Experience


  • User testing
  • Human Factors Regulatory Requirements
  • Engineering Design Controls
  • Medical Device design
  • Verifications/validations
  • Instron testing
  • Manufacturing — Disposables and Devices
  • Design Controls

Education


  • Solid Works
  • Strength of Materials
  • Chemistry
  • Numerical programming
  • Calculus III
  • Physics II
  • Statics
  • Dynamics
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