Katy

2/5/2018
Littleton, CO

Position Desired

Biomedical Engineering
Anywhere in CO; Greenwood Village, CO; Anywhere in OR
Yes

Resume

Accomplished additive manufacturer, design engineer, and researcher of medical implants and devices. Technical and detail oriented, global collaboration, project management, technical leader, extremely organized, excellent problem solver, and a passion for quality work that makes a positive difference.

EXPERIENCE
Project Engineer, Medical Metals Division
3D Systems , Littleton, CO May 2017 –
Jan 2018
• Responsible for TI and SS implant and instrumentation manufacturing for small and large medical device companies
• Responsible for project scope from initial customer meeting through product release to production: guiding customers through 3D printing and manufacturing process, creation of printable designs: implementation of design edits for 3D printability, establish supporting, orientation, printing parameters, and post processing to achieve final desired product.
• Work closely with quality, manufacturing, and logistics to achieve tight customer timelines.
• Project Lead for implementation of 17-4PH SS 320 machine:
­ Responsible for timeline, updates to customer, delegation of tasks, set-up of validation builds: build prep/supporting, running machine, paperwork: manufacturing travelers and reports, external resource communication and logistics, various IQ/OQ/PQ associated tasks.

Principal Engineer, Product Development
Cardinal Health- Orthopedic Solutions Div. (formerly Start-up: Emerge Medical), Denver, CO 2013 - 2017
• Core design engineer helping to release over 1500 SKUs in 9, 510k submissions in less than 12months.
• Responsible for design and development of medical implants and devices from conception through 510k and production
• Responsible for DHF creation and maintenance, 3D CAD designs, drawing creation: tolerancing/GD&T, prototype/product inspection, V/V testing, dimensional analysis, and risk analysis. Worked closely with orthopedic surgeons and suppliers. Helped to mitigate risks and navigate challenges while maintaining tight timelines.
• Engineering Project Lead for:
­ All Cannulated Screw Systems, Locking Plate Line Extensions: Humerus, Clavicle, and Fibula Systems
• Quality Inspection, FAIs, gauging, NCRs. Participated in multiple audits: Internal, Acquisition due diligence, and FDA.
• Supported multiple 510k submissions including writing and technical review.

Biomechanical Research Engineer
University of Florida, Gainesville, FL 2012
• Lab Manager for Comparative Orthopedics & Biomechanics Lab
­ Scheduled project time and aided in multiple studies:
 Canine Total Hip Replacement Study using BFX implants, Strain Gauge analysis of Locking Compression Plate Implants, Canine Cortical Bone Screw Implant Load to Failure testing, Biomechanical Comparison of soft tissue contributions for hip stability
• Biomechanics and Motion Analysis Lab Research Assistant:
­ Temporal-Spatial Parameter Gait Study, Spine Data Analysis using RStats and SPSS, Wrist Movement Study

SKILLS
• Testing experience: Implant and Biomechanical, Sterilization for graphic cases/implants...

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