Summary
Overview
Work History
Education
Skills
Affiliations
Work Availability
Quote
Timeline
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McKenna Kim

McKenna Kim

Forney,TX

Summary

Experienced Reliability Engineer with a demonstrated history in the Medical Device industry and passion for improving lives through high-quality, user-centered design; skilled in Cross-Functional Collaboration and Leadership, Project Management, New Product Development, and Risk Management.

Overview

3
3
years of professional experience

Work History

Reliability Engineer II

Medtronic
Forney, TX
02.2022 - Current
  • Creates and maintains Risk Management files (FMEAs, Product Hazard Analyses, Risk Management Plans/Reports) for over five products and manages team for risk management file remediation efforts (ISO 14971:2019 Updates)
  • Drafts characterization/design verification protocols/reports and coordinates and supports testing to ensure product meets requirements.
  • Collaborates with cross-functional New Product Development team and stakeholders throughout development process and ensures decisions are made with quality and reliability at forefront.
  • Develop User Needs, System Requirements, and Design Inputs/Outputs via collaboration with Marketing and R&D through the Voice of Customer and the Voice of Stakeholders.
  • Mentors and develops talent by providing technical and professional guidance as Intern and Early Career Peer Mentor.
  • Voice of Quality for DMAIC Project to identify potential issues relating to components, suppliers, and manufacturing processes, cross-functional collaboration in prioritization of issues, and execution of component improvements.

Reliability Engineer I

Medtronic
Santa Rosa, CA
06.2020 - 02.2022
  • Guides Cross-Functional Teams and other personnel and ensures that Design Control requirements are being met, including Design Input/Output, Design Verification/Validation, Risk Management, and Test Method Validation.
  • Promotes continuous improvement culture in Design Control activities and proactive utilization of quality tools with design team.
  • Conducts component qualification activities for new and legacy components with Supplier Quality Engineering and R&D Teams.
  • Risk Management (ISO 14971) Subject Matter Expert. Create and release risk management files for new and existing commercial products.

Education

MBA -

Louisiana Tech University
Ruston, LA
05.2024

Master of Science - Engineering And Technology Management

Louisiana Tech University
Ruston, LA
05.2024

Bachelor of Science - Biomedical Engineering

Louisiana Tech University
Ruston, LA
05.2020

Certification - Six Sigma Black Belt

Louisiana Tech University
Ruston, LA
05.2020

Skills

  • Agile Methodologies
  • JAMA Connect
  • Microsoft Project
  • Microsoft Visio
  • ISO 13485 & ISO 14971
  • Risk Management
  • Project Management
  • Statistical Analysis
  • Project Management
  • Statistical Analysis

Affiliations

Society of Women Engineers

  • Co-Chair of Medtronic Women's Network- Bay Area
  • Dare To Be Technical Group, IP Disparity Team Lead
  • Lean In Circle Pillar Lead


Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote

"Maybe it's time for more women to be in charge."
Leslie Knope, Parks and Recreation

Timeline

Reliability Engineer II

Medtronic
02.2022 - Current

Reliability Engineer I

Medtronic
06.2020 - 02.2022

MBA -

Louisiana Tech University

Master of Science - Engineering And Technology Management

Louisiana Tech University

Bachelor of Science - Biomedical Engineering

Louisiana Tech University

Certification - Six Sigma Black Belt

Louisiana Tech University

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McKenna Kim