Celia Valdivia

Manufacturing Engineer

Industrial engineer with extensive experience in medical device assembly, specializing in New
Product Introduction (NPI) and continuous improvement projects. Proactive, results-oriented, and
CONTACT detail-focused, process validation, and optimizing manufacturing operations. My expertise
includes implementing engineering changes, reducing scrap, balancing production lines, and
driving quality improvements, all while mentoring and developing junior engineers and
(664) 491 18 26 technicians.

[email protected] E X P E R I E N C E
https://www.linkedin.com/in/celia- Sustaining Manufacturing Engineer
valdivia-012605156 Enovis / Sep 2023 – Current
• RCA driver for quality improvement project to reduce the CPM in the site.
• Engineering Studies and IQ/OQ/PQ Validations.
• Conducted Engineering Studies and executed IQ/PQ Validations to ensure product
reliability.
• Problem solving through A3 tool, DOE execution, Ishikawa, Pareto chart, CPK Analysis,
EDUCATION Hypothesis test, boxplot.
• Financial analysis for projects and engineering changes.
• Create and update manufacturing documentation, manage deviations, update PMFEA, and
&COURSES balance production lines to optimize labor efficiency.
A. Implemented a saving project by optimizing 3 DL through line balancing, achieving
annual savings of $54,000 USD.
Industrial Engineer B. Operations optimization from the production line through statistical analysis,
Instituto Tecnológico de Tijuana resulting in additional savings of $54,000 USD per year.
Aug 2014 – Jan 2019 C. Increase of the efficiency line from 70 % to 80 %.
Statistics for Medical Process Validation
Grupo palacios portugal Manufacturing Engineer (Sustaining & projects)
May, 2023 Jabil / Sep 2021 – Sep 2023
Lean bronze internal certification • Leader for Engineering Changes implementation from customer (end to end, new PN
creation, PN Documentation, Risk assessment, customer communication, strategy
Jabil validation , materials assurance).
July, 2022 • Training and development of assigned interns, manufacturing technicians and guidance for
Manufacturing Engineer I . (TRESS System)
Lean - Six sigma Course • RCA leader for NCMRs, and CAPAs.
Jabil • Leader for end-of-life changes.
July 2023 • Engineering Sustaining activities (Cycle time, process sheets, monitoring of KPIs as scrap,
productivity).
English course • Solve problems through A3 tool.
Cetys Universidad • Installation Qualification for equipment to improve production line.
2021 • Scrap reduction projects.
A. Achieved $40,000 dlls in cost savings by improving soldering processes, reducing
SOFT SKILLS scrap on the production line.
B. Generated $250,000 dlls in revenue by resolving a critical manufacturing issue.
• Leadership
• Proactive NPI Manufacturing Engineer
• Responsible Flex Medical / Feb 2018 – Sep 2021
• Easy to adapt • Process Transfer Lead
• Assembly Process & NRE’s Quoting
• Teamwork
• Master Validation Plans & Reports
• Effective Communication • Leader for PCN implementation end to end (new PN creation, PN Documentation, Risk
• Emotional Intelligence assessment, customer communication, strategy validation, materials assurance)
• Passionate & Dedicated • Translate design requirements into manufacturing requirements
• Engineering Studies and IQ/OQ/PQ Validations
• Analytical
• Process Capability Analysis for stations, lines, and equipment (Cpk, Ppk)
• Training and development of assigned interns and manufacturing technicians
TECHNICAL • Kaizen leader for identification of improvement projects
• Process Improvements (Pokayoke implementation, line changes, line balancing)
SKILLS • Labeling updates and validations to include new product brand for disposable devices
• Internal NCMR reduction through the creation and implementation of a specific inspection
method for complex ophthalmic devices
• ISO9001, ISO13485 • Sustaining support for flexible assembly lines, dedicated to 20 different SKU’s
• Microsoft project • Equipment and fixturing purchasing
• Experience with Agile, SAP, BAAN & • RCA leader for NCMRs, and CAPAs.
Oracle system A. Implementation of NPI project for Alpine, increasing annual sales to $8 million.
B. Executed a cost-saving project, optimizing processes to save $11,000 annually
• English 75% through line balancing.