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Avatar of Krystle Swain.
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Avatar of Krystle Swain.
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Systems Coordinator @Terumo BCT
2005 ~ 2006
Usability Engineer
More than one year
limited to, risk management documentation. JanDecSystems 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 AprPresent 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 St...
Learning
Intuitive
Human Factors Engineering
Studying
Intern / Interested in working remotely
More than 15 years
CU
Mechanical Engineering

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More than one year
Usability Engineer
Terumo BCT
2020 ~ Present
Denver, CO, USA
Professional Background
Current status
Studying
Job Search Progress
Professions
Fields of Employment
Medical Devices
Work experience
More than 15 years
Management
Skills
Learning
Intuitive
Human Factors Engineering
Medical Devices
Manufacturing
Design
Research and Development
Production Development
Mechanical Engineering
Regulatory Guidelines
powerpoint
highly motivated
communication
Languages
Job search preferences
Positions
Usability Engineer
Job types
Intern
Locations
Remote
Interested in working remotely
Freelance
No
Educations
School
CU
Major
Mechanical Engineering
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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
Resume
Profile

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