Sulata A.
Senior Process Development Engineer at HighLife- Claim this Profile
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Bio
Andrew Zimsen
I have enjoyed working with Sulata for 9 months. She worked on several projects in her role as Metrology Engineer. She has developed a large number of test methods and completed about 20 Test Method Validations. I see Test Method Validations as one of her strengths, because she is so capable at organizing all her TMV requirements, enrolling participants, then quickly following up with the completed report.
Andrew Zimsen
I have enjoyed working with Sulata for 9 months. She worked on several projects in her role as Metrology Engineer. She has developed a large number of test methods and completed about 20 Test Method Validations. I see Test Method Validations as one of her strengths, because she is so capable at organizing all her TMV requirements, enrolling participants, then quickly following up with the completed report.
Andrew Zimsen
I have enjoyed working with Sulata for 9 months. She worked on several projects in her role as Metrology Engineer. She has developed a large number of test methods and completed about 20 Test Method Validations. I see Test Method Validations as one of her strengths, because she is so capable at organizing all her TMV requirements, enrolling participants, then quickly following up with the completed report.
Andrew Zimsen
I have enjoyed working with Sulata for 9 months. She worked on several projects in her role as Metrology Engineer. She has developed a large number of test methods and completed about 20 Test Method Validations. I see Test Method Validations as one of her strengths, because she is so capable at organizing all her TMV requirements, enrolling participants, then quickly following up with the completed report.
Experience
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HighLife
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France
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Medical Equipment Manufacturing
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1 - 100 Employee
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Senior Process Development Engineer
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Jun 2022 - Present
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MicroVention-Terumo
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Manufacturing Process Engineer II
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Jul 2020 - Jun 2022
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Confluent Medical Technologies
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Process Development Engineer I
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Apr 2019 - Jun 2020
-Identified inspection points and designed AQL sampling plans based on product specifications and dimensioned drawings/prints for over 20 different devices -Developed test methods and designed fixturing/tooling for dimensional measurements and functional testing (tensile, leak, burst, and vacuum) for high-volume production of complex catheter product lines -Improved test system repeatability by >10% and achieved significant gains in measurement reproducibility through design, planning, and execution of gauge R&R studies -Performed test method validations and prepared technical documentation for over 50 test reports Show less
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Cook Medical
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Test Engineer
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Jan 2018 - Mar 2019
-Worked cross-functionally with Product Development and Production Engineering stakeholders to capture testing requirements and identify improvements based on test report findings -Drove quality and regulatory compliance initiatives by performing design history file (DHF) gap assessments, providing input for filing submission/renewals, and investigating complaints -Planned and executed verification testing on over 100 different COOK medical devices in a laboratory setting in accordance with Good Laboratory Practices (GLP) per 21 CFR part 58 -Designed standalone and Mark-10/Instron-based test methods, qualified supporting equipment via IQ, and performed end-to-end test method validation (TMV) studies Show less
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actnano, Inc.
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United States
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Nanotechnology Research
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1 - 100 Employee
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Nanotechnology Application Engineer
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Jun 2017 - Jan 2018
-Provided technical demonstrations of Advanced nanoGUARD (ANG) thin-film polymer coating process applied to printed circuit boards (PCBs) supplied by prospective clients -Created engineering specifications and process documentation supporting >10 coating formulations -Developed PVA Delta 6 robot programs to improve process throughout and reduce coating variability -Provided technical demonstrations of Advanced nanoGUARD (ANG) thin-film polymer coating process applied to printed circuit boards (PCBs) supplied by prospective clients -Created engineering specifications and process documentation supporting >10 coating formulations -Developed PVA Delta 6 robot programs to improve process throughout and reduce coating variability
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Education
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2013 - 2017
University of Iowa
Bachelor of Science - BS, Biomedical Engineering -
2009 - 2013
Henry Clay High School
High School Diploma
Community
