Mark Burasinsanga

Manager, Packaging Engineering at Network Partners
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Contact Information
us****@****om
(386) 825-5501
Location
Orange County, California, United States, US

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5.0

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Vipul Rajpara ✯ Global Packaging Professional

Mark was a very organized and productive engineer during his time in my group. He managed a program independently that involved multiple packaging systems and successfully helped the team bring it to Clinical Trial. He showed strong organizational, management, and communication skills throughout the project. Mark also helped train a contractor who was working on the same project. He worked well with cross-functional teams along with his team members in the Packaging Group. Mark was able to deliver on all objectives on or before project deadlines and would be a great asset to any team he is on.

Elon Goldbaum

Mark was a former employee and colleague of mine. Mark is highly analytical and is able to leverage this with making risk-based logical decisions. He has demonstrated time and time again that he is able to balance his technical skills with his project management skills. He has no problem moving out of his comfort zone to manage a non-packaging project with high risk and visibility and deliver on time. Mark’s adaptability has allowed him to expand his background and strengthen his skill set. He is very adept in taking on challenging opportunities, managing teams, and driving projects to completion.

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Credentials

  • Project Management Foundations [2016]
    Lynda.com
    Jul, 2019
    - Nov, 2024
  • Learning Data Analytics
    Lynda.com
    May, 2019
    - Nov, 2024

Experience

    • United States
    • Business Consulting and Services
    • 100 - 200 Employee
    • Manager, Packaging Engineering
      • Jan 2022 - Present

      • Provides Packaging Engineering support for EUMDR programs including design verification and process validation activities aligned with the latest regulations and standards.• Subject matter expert on Packaging related ISO, ASTM, and ISTA Standards.• Participates in risk assessments and project based documentation for Technical Files.• Partners with Product Development, Quality, Operations, Procurement and other functions to assess gaps, plan remediation activities, and author protocols and reports• Mentors Packaging Engineers in project work related to EU MDR remediation Show less

    • Principal Packaging Engineer
      • Jul 2019 - Jan 2022

    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Staff Packaging Engineer
      • Mar 2018 - Feb 2019

      Focused on R&D package engineering and project management support for new product launches, clinical trials, global and limited market releases as well as key operations initiatives.Responsible for meeting timelines, assigning resources, updating project status, and controlling equipment and operational spend.Piloted on-site packaging validation project with third party contract manufacturer in Irving, TX. Completed design verification testing, including component procurement support, sealer troubleshooting, root cause analysis and investigation, and sterilization coordination.Packaging lead of double sterile barrier new product development project manufactured in Draper, UT. Directed sealer validation activities, new tray design, procured components for packaging validation activities.Created analytical spreadsheet which compiled and visually displayed supplier metrics per project for components. Spreadsheet used by Global Supply Chain for strategic decision making and consolidation Show less

    • Senior Packaging Engineer
      • Jan 2017 - Feb 2018

      Completed deliverables needed for Clinical Trial Design Review of new product (currently used in clinical trials) comprised of four systems with unique packaging requirements. In charge of packaging component design, procurement, manufacturing procedure creation, and design verification activities.Worked on design requirements document, DFMEA and PFMEA, IQ/OQ/PQ, specification creation, and shelf life documentation. Leveraged previous testing to avoid redundancy and reduce cost and risk of project Show less

    • United States
    • Medical Equipment Manufacturing
    • 400 - 500 Employee
    • Senior Packaging Engineer
      • Jan 2016 - Jan 2017

      Developed packaging configurations for New Product Development and Sustaining projects andimplemented terminally sterilized packaging in accordance with ISO 11607-1, -2 requirementsParticipated in Kaizen event to address cold chain packaging issues

    • Packaging Engineer
      • Jan 2015 - Dec 2015

      Project manager of material qualification project - leading cross-functional team to secure materials for at-risk product line with annual impact of $7 Million, within 6-monthsInitiated and created Best Practices Packaging Playbook

    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Engineering Manager
      • Oct 2012 - Aug 2014

      Managed team of 3 Engineers and 3 Technicians involved in R&D and Sustaining projectsDirectly contributed to successful resolution of over 300 non-conformance investigations.Managed project workflow using MS Project; communicated across multiple levels of managementResolved major quality issues for internal and external customers, including successful resolution of 8 CAPAs.Qualified 14 sealers used in production and implemented control charts forquality control data using Minitab, that resulted in a drastic reduction of issues and downtime. Show less

    • Senior Packaging Engineer
      • Nov 2011 - Oct 2012

      Provided new packaging design and development, equipment qualification, specification and drawing creation.Increased warehouse and shipping efficiency throughout the company via usage of TOPS Packaging software.Worked extensively with vendors on new packaging test methods and qualifying new packaging materials.

    • United States
    • Packaging and Containers Manufacturing
    • 700 & Above Employee
    • Packaging Engineer
      • Sep 2008 - Nov 2011

      Led packaging design and optimization for food service packaging, managing all aspects from initial design, testing, documentation, artwork approval, specification creation, shipping and loading parameters. Piloted sustainability initiatives and designed 200+ products that led to projected annual savings of $1,721,000. Led packaging design and optimization for food service packaging, managing all aspects from initial design, testing, documentation, artwork approval, specification creation, shipping and loading parameters. Piloted sustainability initiatives and designed 200+ products that led to projected annual savings of $1,721,000.

    • Packaging Engineer
      • Dec 2006 - Sep 2008

      Provided technical support for medical device packaging through new package development and design, qualification of new packaging materials, shipping optimization, specification and drawing creation, and sterilization assessments for packages undergoing ethylene oxide or gamma irradiation.Ensured packaging was in compliance with ISO 11607 standards through evaluation of forming, sealing, wrapping, and assembly processes. Proficient in simulated distribution testing methodsSuccessfully used innovative test methods to reduce the defect rate of a new product by 90% Show less

    • Development Engineer
      • Mar 2006 - Dec 2006

      Provided technical support for medical devices through communication with vendors, new specification creation, addressing product complaints, and writing and execution of scientific protocols.Initiated and completed a design change for a reusable drug delivery system with a distribution of 700,000 units for 2007. Responsibilities included leading team meetings, verification and validation testing, specification streamlining, and risk management analysis of the product.

Education

  • University of Illinois at Urbana-Champaign
    Bachelor of Science Degree, General Engineering

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