Diego Ibarra Email & Phone Number

•Participate in design control meetings and support the development, writing and releasing of manufacturing documentation. Support validation IQ/OQ/PQ protocols, test protocols, and test method validations. Execute provided protocols and write reports to ensure equipment/processes meet part/assembly specifications and regulatory requirements.•Led the validation process (IQ/OQ/PQ) of 23 automated lines increasing annual applicator capacity to 35M units.•Increased the overall automated lines yield from 94% to 98% by implementing new processes and fixtures as well as improving the vision system software, representing a $8M annual cost savings to the Arizona site. •Performed Software V&V for different software revisions (PLC, Vision System, Robot).•Site lead of automated cells, as process and equipment engineer. Lead a team of five engineers. Role includes troubleshooting of equipment on a day to day basis to improve throughput and yield. •Increased the throughput of each automated line from 2200 built parts per day to 4300 by optimizing robot performance (number of alignments, teach point refining).•Worked with maintenance technicians to keep track of inventory of parts/fixtures needed to support production.•Applies statistical methods to estimate future manufacturing requirements, production and fieldperformance data to identify issues and opportunities for improvements.•Plans and performs Design of Experiments (DOE) to determine optimal processing methods andformulation.•Completed a CAPA that increased the reliability of automated equipment performance to >99% by decreasing our top field failure through implementation of an additional Vision System process control.•Hands on investigation and troubleshoot manufacturing issues.•Led and completed the Process Validation of G6 manual lines for the Arizona plant with a 97% yield.Train manufacturing personnel.

Tempe, Arizona

o Administer the Quality Systems, to include Quality performance metrics reports, data analysis, and preparation of presentations, spreadsheets, and reports.o Manage the Sustaining Engineering inbox by reviewing project proposals and gathering necessary details on Stay in Business, Cost Improvement, Quality Issue, and Non-Conformance projects submitted by both internal and external suppliers.o Generate, prepare, and verify weekly and monthly Sustaining Engineering reports consisting of project review sheets, a franchise communication plan, active and proposed projects, and resource utilization data.o Interface with corporate, divisional, and facility quality resources to obtain assessments to generate reports in accordance with applicable company policies.o Provide support of quality management for the preparation, retrieval and archiving of reports as required, utilizing applicable company policies.o Concurrently create, compile, coordinate, and upload Change Control Project Planso Organize meetings for Change Control Teams.o Develop and implement procedures to comply with corporate and industry standards.o Maintain a professional working relationship with internal and external customers, divisions and support staff.o Manage an Action Item Tracker for all Sustaining Engineering projects.o Fulfill general office administrative duties as assigned.o Compose, type, edit, or proofread correspondence, emails, and reports.o Contribute to the success of co-workers by flexibly resourcing special projects

Bachelor Of Applied Science (B.A.Sc.), Biomedical/Medical Engineering

Associates Degree, Biomedical/Medical Engineering