Katelyn Galer Email & Phone Number

Senior analyst in manufacturing technology focusing on industrial edge network components and industrial communications.

Austin, Texas

Serve as manufacturing engineering support for Luminex instruments including process changes and improvements, design transfer, MRB, risk analysis, obsolescence changes, and new supplier part qualifications.- Reduced testing from 36 hours to 11 hours based on data collection and analysis.- Lead Corrective and Preventive Action investigations using root cause analysis, testing, and data analysis to solve customer issues and present to key stakeholders.- Transferred instrument from R&D to manufacturing by creating Manufacturing Instructions, performing process improvements, process validations, and IQ/OQs- Lead Engineering Change Orders from problem analysis, drawing updates, design changes, tolerance analysis, risk review, validations and verifications. Acknowledged for having clear, well defined presentations.

Served as Engineer for development of new products while acting as engineering support for quality and manufacturing of released products in the ECMO field. Performed complaint investigations; worked with suppliers for improving output and dual sourcing.-Developed a new ECMO product by designing components, researching new suppliers, sourcing stocked components, developing timelines, and creating pricing plans and work instructions.-Worked with customers on OEM products including quoting, developing manufacturing instructions, executing testing, and releasing of product.-Created updated Risk Management Procedure per ISO14971 and Design Control Procedure per ISO 13485

Served as Key Development Engineer on specialty stapling device for development and launch, and supported previously launched device. Performed troubleshooting of production issues, worked with suppliers for change requests and test changes and documenting changes through Agile.-Led 510K and verification testing with cross-functional team; summarized data into reports and performed statistical analysis for design inputs and product claims.-Supported marketing in creating customer facing materials to support device performance claims by developing plans, performing testing and analysis for Evidence Based Medicine. -Worked with the quality department, ensuring risk management, failure mode analysis, supplier approval documents up to date.

Served as Key Development Engineer on Single Use specialty stapling device for Phase 1 development and launch. Handled BOM creation and maintenance in Agile, work order creation in BPCS, in-vitro, ex-vivo, and in-vivo testing.-Earned Design for Six Sigma Green Belt by showing correct utilization of tools including Concept Selection, Image Mapping, QFD, FMEAs, T-tests, and DOEs using Minitab.-Performed Voice of Customer by meeting with domestic and foreign surgeons to view surgeries, performing product evaluations, and demonstrating specialty stapling device.-Ensured device ready for launch by successfully creating, executing, analyzing and documenting testing of product specifications.-Facilitated in design, creation, and distribution of bench-top pelvic model for sales representatives.

Assisted in concept and feasibility stages of Single Use Specialty stapling device. Built and tested prototype designs and documented through test reports.-Designed testing fixture, created prints, and fabricated.-Designed and prototyped accessory clamp using Pro-E.

-Designed measurement device-Performed benchmark testing-Helped in cell culture lab-Worked with supplier to bring in new testing equipment

Data Analysis And Visualization Boot Camp

Bachelor Of Science (Bs), Mechanical Engineering

Graduated Summa cum Laude (GPA 3.97), Awarded Ferretti Scholarship Awards and 2007 Sears B. Condit Honor Award