Silvia Lopez Email & Phone Number

Draper, Utah, United States

Draper, Utah, United States

•Responsible for conducting multiple non-conformance investigations for the Product Verification Lab, collaborate with multiple core team members, and support them through their investigations•Ability to solve issues in fast-paced environment ensuring training standards are maintained, equipment is running well, and documentation is clear•Strict attention to detail to prevent changes/updates to procedures or equipment to become issues downstream.•Performed several equipment (IQ) and tooling validations (TFIQ)•Supported multiple engineering test requests (PQ/OQ) from Draper, Irvine and Ireland sites•Supported multiple internal and external audits that resulted in zero findings and minimal recommendations•Supported lead and inspectors throughout the product testing and finished good termination processes•Responsible for procedural updates and improvement projects•Supported training sessions as independent reviewer to certify inspectors to product testing•Ability to step up when team members are absent for long periods of time and ensure the lab stays on task, reducing negative impact on product termination by collaborating with buyer/planners and core team members across all business units.

Ogden, Ut

Experience working in a regulated environment (GMP, GLP and FDA guidelines) Apply relevant engineering principles for the design and development of medical device products Design, plan and conduct laboratory experiments for product development including feasibility testing, prototyping and shelf life studies for dialysate concentrate products ($1-3M USD/year budget projects) Write, review, and development of laboratory protocols, research and development studies, test methods, and validation activities (IQ/OQ) for container closure integrity of dialysate concentrate packaging Collect and analyze data based on laboratory experiments using Minitab and Excel Conduct DOEs to improve capability and assure product specifications and regulations are met. Design and perform MSA and Gage R&R to qualify new equipment for use that enable characterization of critical dimensions. Present engineering decisions to 20+ people based on data analysis from research activitieso Stakeholders, extended teams, and micro teams Ability to meet realistic deadlines based on designed sprints both as a team and individuallyo Accountability for successful completion of design tasks in a collaborative fast-paced environmento Project planning scheduling and tracking: Kanban boards to eliminate waste and improve team delivery process Collaborate with external contractor manufacturers to design, create and acquire project prototypes Report directly to Engineering Project Manager Train new hires locally and in other Fresenius US locations

Ogden, Ut

Provo, Utah Area

Teacher Assistant of several high-level Engineering courses including Biomedical Engineering Principles, Transport Phenomena, Material Science and Polymer Science.

United States

Research Assistant and Team Leader of the Heart Tissue Engineering Research Group • Tissue and cell culture trainer: Focused on the development of regenerative therapies o Project: Creation of beating tissue patches from decellularized porcine cardiac extracellular matrix to treat heart failure disease• Weekly perform decellularization of whole porcine hearts through retrograde perfusion with detergents to obtain cardiac extracellular matrix (cECM) with 98% DNA removal suitable for cell culture and expansion• Daily culture and expansion of adherent mammalian cells such as Induced Pluripotent Stem Cells (hIPS), Endothelial Cells and Cardiac Fibroblasts. Differentiation of hIPS cells into cardiomyocytes• Recellularization of cardiac extracellular matrix to create functional patches of beating cardiac tissue with all cell types described above• Pharmacological stimulation of the cells• Perform Immunohistochemistry (PFA Fixed) and confocal microscopy, Viability/Cytotoxicity assays, cell characterization on both cell culture plates and beating cardiac tissue patches• Experience working with aseptic techniques in a cell culture laboratory environment• Collaboration in the design and development of a prototype suitable for mechanical stimulation of the heart tissue patches• Lead, train and supervise a team of 15 undergraduate students on the heart tissue engineering project. Collaboration in writing grant proposals

Colombia

Instructor of Chemistry and Mathematics freshman courses.

Colombia

INTERFASE Research Group. Volunteer position• Production and optimization analysis in the development of a pyrolysis technology tocreate oil and char from car waste tires.

Master Of Science - Ms, Chemical Engineering

Activities and Societies: Biomedical Club - BYU. Society of Hispanic Professional Engineers SHPE - BYU Chapter

Chemical Engineer, Chemical Engineering