Brenda Pena Email & Phone Number

Rancho Cucamonga, California, United States

Collaborated with leadership to identify and implement new system procedures, optimizing workflows

Rancho Cucamonga, California, United States

Created comprehensive project plans for sustaining commercial development, setting clear goals and metrics to measure team outputsDeveloped an instructional guide for biocompatibility sample submissions, standardizing workflowsIdentified and addressed regulatory gaps for new and commercial product, resulting in successful submission and recertification

Cypress, California, United States

Provide training, encouragement, and athletic advice to prepare students for weekly games of volleyballSchedule, planned and conducted practice sessions throughout summer, preseason, and seasonOrganize tournaments for the girls volleyball team as a fundraiser for the programCoordinate bonding events for the players across both boys and girls volleyball programs

Orange County, California, United States

Led core-team meetings to review design data, planned risk mitigation, and facilitated decision-makingEstablished design requirements for a blood diagnostic consumable using lean six sigma methodologies such as requirement flow down and SIPOCCreated and validated test methods for bubble leak, dye penetration and visual seal evaluation in accordance with ASTM 2096, ASTM F3039, and ASTM F1886 for feasibility evaluationsDeveloped a governance procedure for serialization and packaging… Show more Led core-team meetings to review design data, planned risk mitigation, and facilitated decision-makingEstablished design requirements for a blood diagnostic consumable using lean six sigma methodologies such as requirement flow down and SIPOCCreated and validated test methods for bubble leak, dye penetration and visual seal evaluation in accordance with ASTM 2096, ASTM F3039, and ASTM F1886 for feasibility evaluationsDeveloped a governance procedure for serialization and packaging to align processes across multiple manufacturing locationsDesigned primary, secondary, and tertiary packaging for consumables, following root cause investigations of the existing in-house designLed material evaluations and characterization of components, ensuring alignment with user and product requirementsQualified new suppliers for production and prototype components during Phase 2 at a startupProvided test plans and status updates for upper management review, facilitated decision-making and mitigated risk Show less

Santa Rosa, California

● Lead packaging development programs for drug coated devices from initiation to commercializationo Harmonize working relationships with cross functional members and leadership to collaborate on strategies and impacts to PDP programso Analyze VOC and provide justifications/rationales for design requirement changeso Evaluate the risks, plan for mitigations and manage impacts for packaging from feasibility to verification resulting in DV right first time o Articulate and discuss… Show more ● Lead packaging development programs for drug coated devices from initiation to commercializationo Harmonize working relationships with cross functional members and leadership to collaborate on strategies and impacts to PDP programso Analyze VOC and provide justifications/rationales for design requirement changeso Evaluate the risks, plan for mitigations and manage impacts for packaging from feasibility to verification resulting in DV right first time o Articulate and discuss with directors and senior management the status and approaches for packaging on product development programso Facilitate technical reviews with independent reviewers with test results and plans for next phase project approvalo Support submissions for US and OUS regulatory bodies for peripheral vascular drug coated balloonso Delivered components from concept generation to production four (4) months prior to the deadlineo Pulled in deliverable timelines for US commercial launch components by 3 months● Design packaging components for product development programs in peripheral vascularo Authored operating procedures, material specifications, engineering build requests and verification protocols and reportso Used design for reliability manufacturability tools (requirement flow down, brainstorming and PUGH matrices) to assess concepts resulting in streamlined decision-making processes and alignmento Simulated interactions between the device and packaging components using Solidworks and FEA resulting in robust designs and lower risk to DV right first timeo Performed Minitab analysis for seal tensile strength data acquired in design freeze and verificationo Outlined and executed test methods for visual inspection and device removal testing, as well as material characterizationo Developed and created assembly fixtures for COS manufacturing combining two product lines resulting in less material on the line and faster assembly process Show less

Santa Rosa, Ca

Santa Rosa, California

Department: Global Packaging and LabelingPrevious: Packaging Innovation

Riverside, Ca

Degree in Bioengineering, B.S.Society of Women Engineers at UCR, President (2014-2015)Bourns College of Engineering, Leadership Council, President (2014-2015)Society of Women Engineers at UCR, Social Chair (2013-2014)Society of Women Engineers at UCR, Sports Manager (2013)Bourns College Engineering Day Committee Member (2012-Present)

Northridge, Ca

Mechanical Engineering Intern in Research and DevelopmentDeveloped and conducted test plan for material characterization and testingPerformed CAD revisions for FEA using Solidworks and ANSYS Mechanical