Madeline Wendt
Product Development Engineer at Kymanox- Claim this Profile
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Bio
Experience
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Kymanox
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United States
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Biotechnology
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100 - 200 Employee
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Product Development Engineer
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Mar 2023 - Present
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BD
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Quality Engineer
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Nov 2019 - Mar 2023
• Reviewed and analyzed documentation from legacy product lines to ensure compliance with new EU MDR requirements and state of the art standards. • Proficiency in EU MDR Regulations and numerous ISO, ANSI, AAMI, ASTM, and USP Standards• Create and maintain various types of documentation (FMEAs, Risk Analyses, Benefit-Risk Analyses, Post Market Surveillance Plans and Reports)• Communicated project phases to upper management through design reviews•Write and/or review test methods and their validations.• Write and/or review design verification and validation protocols and reports and test plans• Performed statistical data analysis using Minitab• Participated in internal and supplier audits. Show less
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Quality Engineer Intern
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Jun 2019 - Nov 2019
• Helps generates formal test protocols and reports• Maintains accurate data and organizes and presents data in a reportable format• Participates on cross-functional teams to develop risk assessment• Assists in system assurance including documentation, testing and inspection, product and process development, and non-conforming product investigations.
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Fluidic Energy
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United States
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Oil and Gas
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1 - 100 Employee
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R&D and Engineering Test Intern
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Mar 2018 - Oct 2018
• Troubleshooting and resolving software and hardware faults in batteries • Assists in experiments to determine causes of failure within battery • Perform data analysis on lab results and possible optimizations in active units • Conduct experiments creating proprietary polymers and monitoring electrochemistry within the batteries • Helped develop new formulas for production use • Troubleshooting and resolving software and hardware faults in batteries • Assists in experiments to determine causes of failure within battery • Perform data analysis on lab results and possible optimizations in active units • Conduct experiments creating proprietary polymers and monitoring electrochemistry within the batteries • Helped develop new formulas for production use
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Education at Work
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United States
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Outsourcing and Offshoring Consulting
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400 - 500 Employee
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Work Force Analyst
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Jun 2016 - Mar 2018
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Education
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Arizona State University
Chemical Engineering, Chemical Engineering -
Maricopa Community Colleges
Chemical Engineering, 3.1