Microsoft Office Engineering
Resume:
Professional Experience
R&D Engineer
CuraSeal, Inc. Santa Clara, CA Dec 2017 – Jun 2018
• Designed and created company UDI labels in compliance with 21 CFR Part 830.
• Developed UDI label specification requirements and procedural documentation.
• Executed IQOQ & PQ validation protocols and produced respective reports.
• Generated CAD and engineering drawings for company tools and products.
• Devised a procedure for testing product saturation limits.
• Designed and fabricated a prototype human rectum model. QA Product Complaints Specialist
Philips Rancho Cordova, CA Nov 2015 – Dec 2017
• Aided in the completion of a backlog of 10,000+ complaint records four months ahead of schedule.
• Performed device functional analysis on returned IVUS systems, sub-assemblies, and catheter products to identify the root cause of device malfunctions.
• Assured that finished products met all acceptance criteria as specified by their MPs and that all DHRs were correct and complete.
• Reduced training time for new hires by 25% by improving upon set procedures. QA Product Complaints Coordinator
Philips Rancho Cordova, CA Sep 2015 – Nov 2015
• Recorded incoming product complaints in accordance with cGDP.
• Managed and performed customer communication regarding complaint statuses and product replacement assessment for returned devices.
• Familiarized with 21 CFR 820, 21 CFR 803, ISO 9001:2015, and ISO 13485:2016. Transit Driver
ASUCD Unitrans Davis, CA Jul 2013 – Sep 2015
• Demonstrated advanced multitasking and quick decision making skills in a fast- paced work environment.
• Completed 1,000+ driving hours safely with no reported incidents. Education University of California, Davis Graduated Jun 2015 Bachelor of Science, Biomedical Engineering
Projects Senior Design Capstone Project Jan 2015 – Jun 2015
• Designed and manufactured a prototype point-of-care blood analysis device to diagnose tuberculosis.
• Composed reports detailing device life cycle including DHF, engineering design specifications, verification and validation plans, and FMEA data.
• Applied good manufacturing practices, green engineering principles, and six sigma concepts to fabricate finished prototype.
• Collaborated with teammates to plan and meet project timelines and deadlines. Skills Programs: • Solidworks • Microsoft Office Suite • MatLab • LabView Machine Shop Certified: • Lathe • Mill • Drill Press • Sander JUSNIDEO SANTOS QUINTOS III
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