Brenda Pena

Brenda Pena Email and Phone Number

Principal Engineer @ New World Medical | Design Transfer, Process Improvement @ New World Medical
rancho cucamonga, california, united states
Brenda Pena's Location
Anaheim, California, United States, United States
Brenda Pena's Contact Details

Brenda Pena personal email

About Brenda Pena

Leading the charge in manufacturing process enhancement and design transfer at New World Medical, my role as Principal Engineer revolves around driving product quality and operational excellence. Mastery of Design Controls, Solidworks and a keen eye for root cause analysis have empowered our team to make significant strides in advancing medical technology to the forefront of the market. We've enacted robust design controls and streamlined processes that underpin the commercialization of innovative medical solutions.My sustained engagement in coaching at Oxford Academy has paralleled my engineering pursuits, nurturing discipline, and teamwork in young athletes. This dual expertise in engineering and coaching has cultivated a unique skill set that leverages strategic planning and a commitment to excellence, ensuring that whether on the factory floor or the volleyball court, quality and growth remain our constants.In my previous roles as a functional leader on new product development projects and sustaining projects, I’ve led multi and cross functional teams to deliver on time and streamlined design and process solutions for commercialization and implementation across several product lines. As part of my MDR experience, I’ve gained understanding of regulatory and quality standards required by several governing bodies and used that knowledge to plan project timelines and prevent and adapt to challenges successfully.

Brenda Pena's Current Company Details
New World Medical

New World Medical

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Principal Engineer @ New World Medical | Design Transfer, Process Improvement
rancho cucamonga, california, united states
Employees:
105
Brenda Pena Work Experience Details
  • New World Medical
    Principal Engineer, Design Transfer
    New World Medical Aug 2023 - Present
    Rancho Cucamonga, California, United States
    Collaborated with leadership to identify and implement new system procedures, optimizing workflows
  • New World Medical
    Principal Sustaining Engineer
    New World Medical Nov 2022 - Jul 2023
    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
  • Anaheim Union High School Dst
    Girls Frosh / Boys Jv Coach, Oxford Academy
    Anaheim Union High School Dst Oct 2020 - Present
    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
  • Sequoia Consulting Group,Llc
    Project Manager
    Sequoia Consulting Group,Llc Sep 2021 - Sep 2022
    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
  • Medtronic
    Packaging Engineer
    Medtronic Mar 2018 - Sep 2021
    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
  • Medtronic
    Mdr Program Lead
    Medtronic Jun 2019 - Feb 2020
  • Medtronic
    Associate Packaging Engineer
    Medtronic Jul 2016 - Feb 2018
    Santa Rosa, Ca
  • Medtronic
    Engineering Contingent (Packaging Engineering)
    Medtronic Sep 2015 - Jun 2016
    Santa Rosa, California
    Department: Global Packaging and LabelingPrevious: Packaging Innovation
  • University Of California, Riverside
    Undergraduate Student
    University Of California, Riverside Sep 2011 - 2015
    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)
  • Medtronic
    Undergrad Intern Tech (Mechanical R&D)
    Medtronic Jun 2014 - Sep 2014
    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

Brenda Pena Skills

Microsoft Office Matlab Microsoft Excel Microsoft Word Powerpoint Public Speaking Comsol Solidworks C++ Teamwork Leadership Biomedical Engineering Pspice Design Research Microsoft Powerpoint Engineering Management Data Analysis Simulink Html Labview Biomechanics Ansys Finite Element Analysis Minitab Oracle Agile Plm Higher Education Design Verification Testing Project Management Concept Generation

Brenda Pena Education Details

Frequently Asked Questions about Brenda Pena

What company does Brenda Pena work for?

Brenda Pena works for New World Medical

What is Brenda Pena's role at the current company?

Brenda Pena's current role is Principal Engineer @ New World Medical | Design Transfer, Process Improvement.

What is Brenda Pena's email address?

Brenda Pena's email address is p_****@****hoo.com

What schools did Brenda Pena attend?

Brenda Pena attended University Of California, Riverside.

What are some of Brenda Pena's interests?

Brenda Pena has interest in Science And Technology, Children, Education, Health.

What skills is Brenda Pena known for?

Brenda Pena has skills like Microsoft Office, Matlab, Microsoft Excel, Microsoft Word, Powerpoint, Public Speaking, Comsol, Solidworks, C++, Teamwork, Leadership, Biomedical Engineering.

Who are Brenda Pena's colleagues?

Brenda Pena's colleagues are Angela Brady, Rey Morales, Diana De Alba, Jermery Owens, Jennifer Borja, Northeastern University, Graduate Student, Sergio Heredia, Jorge Avalos.

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