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
Genesee, CO
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
Lakewood, CO
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
Lakewood, CO
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
Lakewood, CO
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
Lakewood, CO
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