Krystle Swain
Denver,CO
Summary
Forward-thinking R&D Engineer analytical in approaching industry problems. Extensive experience in research and development, design, and production of complex systems.
Strong understanding of end-to-end medical device manufacturing processes. Passionate about developing new technologies and products that improve lives.
Overview
17
17
years of professional experience
Work History
Mechanical Engineering Intern
Arcscan, Inc
03.2022 - 08.2022
- Designed test fixtures and test procedures to characterize undefined components of the system.
- Instructed engineering team in computational fluid dynamics analysis. Modeled complex, enclosed fluid pathways, saving money on physical prototypes.
- Organized root cause analysis activities on product failures. Devised testing to address failures, reduce causes of failures and highlight manufacturing process improvement activities.
- Generated SOPs and work instructions to allow for more accurate manufacturing and field service procedures and decrease product failure.
Engineering Intern
Terumo BCT
03.2021 - 08.2021
- Lead cross-functional team for design and development of new disposable products. Met development deadlines following company design processes.
- Engineered drawings and prototypes for first design concepts.
- Executed test protocols and reports for various test procedures, performed during feasibility of the design.
- Originated user needs and product requirements based on market research, reducing current product issues.
R&D Usability Engineer
Terumo BCT
11.2018 - 02.2021
- Conceived and supervised a variety of human factors studies. Finding usability issues early in the design process, saving the company money in costly redesign.
- Instituted new technologies to support software development.
- Conceptualized studies around user interfacing software. Reducing the difficulty of use for the customer in the final design.
- Oversaw human factors work, including documentation, for several large projects across various product lines.
- Skilled at working independently and collaboratively in a cross-functional team environment.
Innovation & Design, Engineering Technician
Terumo BCT
01.2007 - 01.2018
- Developed end-to-end disposables and created work instructions during R&D to reduce variance between new builds
- As a subject matter expert was valuable resource in FMEA design for disposables and devices
- Identified root-cause of system failures through analysis and planned changes in manufacturing processes to reduce failures
- Initiated several large protocols (validations/verifications) for a system in design, supporting an understaffed engineering team
- Repaired and fabricated devices for a large in-house lab and a few small labs, in-field for R&D customers. Building customer relations and product recognition
Systems Coordinator
Terumo BCT
11.2005 - 01.2007
- Oversaw continuous development of tools and workflows for a manufacturing
- Responsible for documentation implementation and record retention for manufacturing
- Monitored and tested assembly operations to identify potential bottlenecks and collaborate with developers on solution implementation.
- Delivered training and instructional presentations, focusing on efficiency and safety.
- Monitored participant workflow and behaviors throughout training process.
Education
Bachelor of Science - Mechanical Engineering
University of Colorado
Denver05.2023
Skills
- Engineering Design Controls
- User Research
- Continuous Improvements
- Disposable and Device Manufacturing
- CAD - Solidworks
- 3D Printing & Optimization
- Laser Cutting
- Familiar with ISO, FDA, MDR standards and regulations
Timeline
Mechanical Engineering Intern
Arcscan, Inc
03.2022 - 08.2022
Engineering Intern
Terumo BCT
03.2021 - 08.2021
R&D Usability Engineer
Terumo BCT
11.2018 - 02.2021
Innovation & Design, Engineering Technician
Terumo BCT
01.2007 - 01.2018
Systems Coordinator
Terumo BCT
11.2005 - 01.2007
Bachelor of Science - Mechanical Engineering
University of Colorado
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