Mauricio Porras

Results-driven Chemical Engineer with a strong foundation in Medical Sciences and a proven track record in research, investigation, and process improvement within manufacturing operations. Exceptional skills in process and product design, regulatory compliance, and continuous, complemented by effective communication and high adaptability.

Senior R&D Validation Engineer at ICU Medical Costa Rica (2024-05 – Present)

• Led design validation efforts for FDA regulatory submissions, ensuring compliance and facilitating the seamless integration of newly acquired infusion pump products.
• Execution of validation studies with end users including pharmacists, biomedical engineers and clinicians as part of the Design Validation and Verification activities.
• Provided design validation insights to development teams, contributed to labeling updates based on simulated user testing, and collaborated with verification teams to develop and execute test cases for design verification.

Process Development Engineer at Establishment Labs Costa Rica (2022-09 – 2024-05)

• Executed design validation activities, as part of a multidisciplinary team, contributing to the successful FDA 510k clearance for U.S. commercialization.
• Led and execute all process validations for the company´s first product to enter the U.S market, yielding favorable outcomes and facilitating the initiation of procedures in the U.S.
• Formulated and executed strategies for Value Improvement projects, resulting in annual savings of $80k. This involved innovative approaches such as equipment and process redesign, coupled with technical investigations to ensure sustained and effective change implementation.

Manufacturing Engineer at Abbott Structural Heart Costa Rica (2021-01 – 2022-09)

• Spearheaded and directed the strategic initiatives essential for the successful sustenance and optimization of the night shift assembly production line. Collaborated seamlessly with a cross-functional team, implementing innovative approaches and sustaining activities that played a pivotal role in achieving heightened production efficiency and surpassing yield goals during the crucial ramp-up phase.
• Guided activities in local and international Kaizen events, assessing inspection methods and suggesting innovative aids/fixtures, resulting in a notable 5% yield improvement. Additionally, coordinated initiatives to enhance the onboarding process for newly hired assembly operators.
• Led comprehensive equipment and software validation efforts, overseeing calibration and maintenance coordination. Executed Installation Qualifications in strict adherence to medical industry regulations, ensuring seamless functionality for the ongoing expansion process.

Licenciate in Chemical Engineering – Universidad de Costa Rica

B. Sc in Medicine – Universidad de Costa Rica

Certification in Process Validation – AAMI

Certification in Six Sigma Black Belt – Six Sigma Academy Amsterdam

Certification in Introduction to Project Management – Universitat Politécnica de Valencia (UPV)