Breanna Padasak

About Breanna Padasak

I\'m an Engineering Nerd who specializes in taking the unknown and making it known. Relocated to Bend, Oregon this August (2025). I like solving and implementing solutions to problems. Currently working as a Manufacuring Engineer at Medline Renewal. Previously worked as a Green Belt Certified Staff Manufacturing Engineer for the Neurovascular division in Salt Lake City, Utah. Focused on implementing cost saving fixtures and equipment, finding process improvements, GMP, and preventing line down situations. Previous experience in new product development designing and remediating sterile and non-sterile packaging systems as well as labeling.•Experience translating ISO 11607-1:2020 and ISO 11607-2: 2020 and designing packaging systems for terminally sterilized products for internal product development teams. Working knowledge of ASTM D4169 and ISTA 3A/ISTA 4AB and palletization software TOPS to redesign an Ethylene Oxide sterilization packaging system.•Experience translating USP Container Closure Integrity Testing to procure equipment, perform testing, and assess preformed vial, stopper, and cap configurations for a cold chain drug product. •Knowledge and hands-on experience of design control, mold and process validations, sampling plans, root cause analysis (CAPA), FMEA, and development.•Experience utilizing CAD software, Professional Engineer, CREO, and SolidWorks, to create 3D parts, assemblies, and drawings for manufacturing.•Understanding of Orthopedic and Neurovascular product offerings and packaging development developed through a challenging curriculum including biosolid and solid mechanics, and biomedical computation and statistics at the University of Rochester as well as previous Engineering roles. •Ability to create validation protocols that include process verification and component validation through MSA, GR & R, FAI, DOE, IQ, OQ and PQ•Ability to design and analyze biomechanical structures using the finite element analysis program, Abaqus FEA.•Efficiently utilize MATLAB, MiniTab, Microsoft Excel and Office, LabChart7 and Image J to evaluate and analyze data, create charts, and display movies to solve problems. •Ability to perform basic statistical and capability analysis techniques on Minitab and perform tolerance stack-up analysis techniques using GD & T understanding. •Teamwork and communication skills demonstrated through projects produced in quality assurance and product development teams at Stryker, Smith & Nephew, DiscGenics, Plastikos, Inc, and Acumed, LLC.

Experience

1. Senior Manufacturing Engineer

   Medline

   Apr 2026 — Present · Redmond, OR, US

Education

• University of Rochester

  Bachelor of Applied Science (B.A.Sc.), Biomedical/Medical Engineering

  2010 — 2014

• McDowell High School

  GED, College Track

  2006 — 2010

Skills

• Gd&T
• Injection Molding
• Biomechanics
• Cad
• Matlab
• Medical Devices
• Capa
• Root Cause Analysis
• Quality Assurance
• Lean Manufacturing
• Microsoft Office
• Research
• Technical Writing
• Supplier Quality Engineering
• Public Speaking
• Blueprint Reading
• Continuous Improvement
• Statistics
• Verification and Validation (V&V)
• Finite Element Analysis
• Engineering
• Geometric Dimensioning
• Leadership
• Fmea
• Iso 13485
• Data Analysis
• Quality System
• Customer Service
• Minitab
• Design of Experiments
• Manufacturing
• Microsoft Excel
• Powerpoint
• Skillful Use of Simulink a Simulation and Model Based Design Software Integrat
• Biomedical Engineering
• Design Control
• Microsoft Word
• Solidworks
• Validation
• Geometric Dimensioning