Kristin Abele Email and Phone Number
Kristin Abele work email
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Kristin Abele personal email
As a developmental quality engineer in Abbott's Cardiac Rhythm Management Division, I work with cross-functional teams to ensure active implantable medical devices (AIMDs) are safe and effective by thoughtfully planning design controls and executing design verification and validation testing. I have a strong passion for helping others and inspiring the next generation of STEM leaders through outreach programs.
Abbott
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Senior Development Quality EngineerAbbott Jul 2024 - PresentAbbott Park, Illinois, Us-Authored, owned, and executed design verification testing on newly developed products and products undergoing design changes.-Led and participated in numerous projects through various stages of product life-cycle including design, verification and validation, and transfer to manufacturing.-Collaborated cross-functionally for development of design input requirements, FMEAs, and risk management profiles to comply with AAMI design control requirements.-Prepared documents for design history files to support submissions to regulatory agencies and notified bodies (FDA and TUV).-Participated and supported internal and external inspections.-Evaluated product/material discrepancies, implemented corrective actions for closure of CAPA/NCMR. -
Development Quality Engineer IiAbbott Sep 2021 - Jun 2024Abbott Park, Illinois, Us-Authored, owned, and executed design verification testing on newly developed products and products undergoing design changes.-Led and participated in numerous projects through various stages of product life-cycle including design, verification and validation, and transfer to manufacturing.-Collaborated cross-functionally for development of design input requirements, FMEAs, and risk management profiles to comply with AAMI design control requirements.-Prepared documents for design history files to support submissions to regulatory agencies and notified bodies (FDA and TUV).-Participated and supported internal and external inspections.-Evaluated product/material discrepancies, implemented corrective actions for closure of CAPA/NCMR. -
Development Quality Engineer IAbbott Oct 2020 - Sep 2021Abbott Park, Illinois, Us-Authored, owned, and executed design verification testing on newly developed products and products that were undergoing design changes.-Conducted engineering characterization testing and results analysis.-Assisted with the development of design input requirements, FMECAs, and risk management profiles to maintain compliance to appropriate design controls procedures.-Prepared documents for design history files to support submissions to regulatory agencies and notified bodies (FDA and TUV). -
Chemistry Learning AssistantCalifornia Polytechnic State University-San Luis Obispo Jan 2018 - Jul 2020San Luis Obispo, Ca, UsDemonstrated excellent teamwork, organizational, communication skills by aiding with laboratory safety, and facilitating student discussions to help students achieve a better understanding of chemistry concepts -
Biomedical Engineering Teaching AssistantCalifornia Polytechnic State University-San Luis Obispo Sep 2019 - Mar 2020San Luis Obispo, Ca, UsDemonstrated excellent communication, organizational, and time management skills by teaching undergraduate students MATLAB programming skills and debugging mathematical models for various aspects of Biomedical Engineering -
Western Blot Biological Assay Masters ProjectHp Sep 2019 - Jun 2020Palo Alto, Ca, Us•Worked in a team of two master's students with engineers at HP Life Sciences to optimize Western Blots•Improved target quantification and multiplexing through DOE execution and the development of custom protocols -
Research & Development InternSilara Medtech Jun 2019 - Sep 2019Santa Rosa, California, Us• Improved bench testing through the development of a hybrid model for Transcatheter Heart Therapies• Formulated and executed PQ and PPQ protocols and final reports for medical device validation • Applied strong skills with engineering drawings and principles to develop MS and TS and medical device drawings -
Upright Sleep Device Senior ProjectBonna Vita Ventures, Llc Sep 2018 - Mar 2019Upright Sleep Device Senior Project Main Point of Contact and Primary Investigator• Created a Class I Medical Device to aid patients in sleeping upright post-surgery to meet design specifications• Considered the Food and Drug Administration (FDA) regulations and quality standards through risk management and Failure Modes and Effects Analysis (PFMEA and DFMEA)• Manufactured and performed mechanical testing on prototype and raw materials to ensure product quality and reliability through the creation and implementation of Manufacturing Process Instructions (MPI) and testing protocols• Primary Investigator (PI) for Institutional Review Board (IRB) approved human subject safety and effectiveness testing• Completed project on time and under budget through strong engineering economic and project management skills
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Research & Development InternImperative Care Jun 2018 - Sep 2018Campbell, California, Us• Developed a polymer coating process to reduce thrombogenicity in Nitinol neurovascular devices • Formulated and executed IQ/OQ protocols and final reports for medical device validation• Applied Keyence and Instron skills to aid with product testing -
Sup Board Team MemberQuality Of Life Plus Program (Ql+) Sep 2017 - Jun 2018Mclean, Virginia, UsDesigned and prototyped a SUP Board attachment for Capital SUP to be used by single lower leg amputees. -
Server And CashierPanera Bread Jun 2015 - Sep 2017St Louis, Mo, Us -
Dance InstructorClayton Valley Dance Academy Jun 2012 - Jul 2017
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Transportation System For Terra Team MemberQuality Of Life Plus Program (Ql+) Sep 2016 - Jun 2017Mclean, Virginia, Us• Collaborated with a small group of interdisciplinary engineering students at Cal Poly to tackle a challenge proposed by challenger(Terra Lynch, a teen diagnosed with Cerebral Palsy)• Built a remote-controlled robotic device that assists with daily tasks -
Server And CashierPieology Pizzeria Jun 2014 - Oct 2014Rancho Santa Margarita, California, Us
Kristin Abele Skills
Kristin Abele Education Details
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California Polytechnic State University-San Luis ObispoBiomedical Engineering -
California Polytechnic State University-San Luis ObispoBiomedical Engineering
Frequently Asked Questions about Kristin Abele
What company does Kristin Abele work for?
Kristin Abele works for Abbott
What is Kristin Abele's role at the current company?
Kristin Abele's current role is Sr. Development Quality Engineer at Abbott | Student Programs (SWENext) Committee Member, Society of Women Engineers.
What is Kristin Abele's email address?
Kristin Abele's email address is kr****@****ott.com
What schools did Kristin Abele attend?
Kristin Abele attended California Polytechnic State University-San Luis Obispo, California Polytechnic State University-San Luis Obispo.
What skills is Kristin Abele known for?
Kristin Abele has skills like Microsoft Office, Critical Thinking, Teamwork, Solidworks, Community Outreach, Research, Project Management, Verification And Validation, Research And Development, Data Analysis, Sewing, 3d Printing.
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