Cesar A. Puente
Summary
Detail-oriented Bioengineering graduate student with hands-on engineering experience in operations, quality assurance, and process optimization within the medical device industry. Skilled in documentation management, PFMECA analysis, SAP systems, and regulatory compliance. Experienced in clinical research coordination and data analysis. Fluent in English and Spanish.
Overview
2
2
years of professional experience
Work History
Operations Engineering Co-op Intern
Abbott Laboratories
01.2024 - 09.2024
- Oversaw documentation revisions (IQRs, raw material specs, fixture records) per Good Documentation Practices (GDP), enhancing audit readiness and reducing compliance gaps.
- Conducted Process Failure Mode, Effects, and Criticality Analysis (PFMECA), refined tolerances, and improved capability indices (Cpk) for production processes.
- Coordinated IQ/OQ/PQ validations, ensuring regulatory compliance and optimal performance ranges.
- Led First Article Inspections (FAI) on new tooling, aligning with ASME standards to minimize production delays.
- Managed Engineering Change Requests (ECRs) and Change Orders (COs), coordinating cross-functional integration with manufacturing and quality systems.
- Utilized SAP for efficient Bill of Materials (BOM) management and Manufacturing Order (MO) tracking, improving supply-chain efficiency.
- Facilitated cross-functional collaboration with Quality, Manufacturing, and R&D to resolve production and tooling issues promptly.
Clinical Research Coordinator
U.S. Department of Veterans Affairs
06.2023 - 01.2024
- Coordinated clinical research study: “Prostate Specific Membrane Antigen (PSMA) Scan and Multiparametric MRI for Prostate Biopsy Detection of Clinically Significant Prostate Cancer.”
- Managed study budgets and ensured efficient utilization of allocated resources.
- Successfully enrolled and completed 13 out of 100 targeted subjects.
- Collected, analyzed, and maintained data integrity from imaging, laboratory tests, and biopsies using REDCap.
- Maintained rigorous documentation compliance including case reports, consent forms, and regulatory documents as per IRB standards.
Research Assistant
U.S. Department of Veterans Affairs
11.2022 - 06.2023
- Assisted in data collection, analysis, and manuscript preparation for the REFINE-PET Registry.
- Supported data collection activities for studies including Systematic 18F-FDG PET Evaluation and 82Rb-Chloride PET MPI.
- Acted as a medical assistant performing pain assessments, taking basic vitals, and handling blood samples for SPLASH clinical trials.
Education
Master of Science - Bioengineering
University of California, Los Angeles
Los Angeles, CA08.2025
Bachelor of Science - Biology
University of California, Los Angeles
Los Angeles, CA06-2022
Skills
- Engineering Software: SAP, Excel (advanced), Acrobat Pro
- Quality & Regulatory: GDP, ISO standards, PFMECA, IQ/OQ/PQ, FDA regulations, ASME standards
- Process Improvement: Lean Manufacturing, Continuous Improvement (IPO methodology)
- Laboratory: Dissecting, Pipetting, Bacterial Transformation, Staining, Blood Smearing
- Language: English, Spanish (Fluent: Speak, Read, Write)
- Cross-functional coordination
- Microsoft office
- Project planning
- Root cause analysis methods
Awards
UCLA Gluck Fellowship Award (2020, 2021), State of California Senate Certificate of Recognition (2019), State of California Lieutenant Governor Certificate of Recognition (2019), City of Los Angeles Certificate Recognition (2018)
Timeline
Operations Engineering Co-op Intern
Abbott Laboratories
01.2024 - 09.2024
Clinical Research Coordinator
U.S. Department of Veterans Affairs
06.2023 - 01.2024
Research Assistant
U.S. Department of Veterans Affairs
11.2022 - 06.2023
Master of Science - Bioengineering
University of California, Los Angeles
Bachelor of Science - Biology
University of California, Los Angeles
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