Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

LuAnne Cherwinka

Plymouth

Summary

Results-driven Senior Business Analyst with extensive experience at Medtronic, specializing in User Acceptance Testing (UAT) and fostering cross-functional collaboration. Recognized for effectively aligning technical requirements with business objectives, achieving regulatory compliance and driving process enhancements. Proven ability to lead critical projects that improve system functionality and elevate stakeholder satisfaction.

Overview

18
18
years of professional experience
1
1
Certification

Work History

Senior Business Analyst, Consultant

Ecolab
07.2024 - 11.2024

ThoughtSpot Sage (Advanced AI-powered analytics)

  • Developed and executed UAT testing strategies for an AI-powered analytics platform, ensuring alignment with business requirements and stakeholder needs
  • Collaborated with district sales managers to translate business needs into actionable test cases and scenarios, ensuring system functionality met end-user expectations
  • Managed defect resolution by working closely with technical teams and vendors, ensuring issues were resolved or added to the project backlog for future prioritization
  • Provided detailed UAT status updates to stakeholders, ensuring transparency and alignment throughout the testing process

Senior Business Analyst, Consultant

Boston Scientific (formerly Preventice)
07.2023 - 06.2024

Dynamics 365 Sales Hub (CRM) / Anaplan for Quotas and Commissions

  • Conducted compliance reviews of healthcare professional contracts, ensuring adherence to regulatory standards (e.g., HIPAA, 21 CFR Part 820)
  • Developed and executed UAT test cases for Dynamics 365 Sales Hub and Anaplan, ensuring system functionality aligned with business requirements
  • Streamlined the sales compensation process by implementing Anaplan, including creating detailed process documentation and work instructions for executive leadership
  • Partnered with IT and business stakeholders to identify test data and environments, ensuring comprehensive UAT coverage

Principal IT Software Project Lead

Medtronic
10.2019 - 01.2023
  • Led UAT efforts for a global product complaint application, ensuring system functionality met regulatory requirements (e.g., 21 CFR Part 820, ISO 13485)
  • Developed and maintained validated documentation within the system of record (Documentum), ensuring compliance with regulatory standards
  • Conducted gap analyses during company acquisitions, identifying and addressing process integration challenges
  • Partnered with regulatory teams to ensure systems maintained a validated state, facilitating successful UAT sign-offs

IT Quality Test Team Lead

Medtronic
10.2015 - 09.2019
  • Implemented IT Quality Management System (QMS), ensuring compliance with 21 CFR 820.5 and ISO 13485
  • Managed global QA testing teams, optimizing vendor costs while maintaining quality standards and delivery timelines
  • Led internal IT audits, developing and executing compliance checklists to ensure adherence to medical device quality standards

Business Analyst

Medtronic
10.2006 - 09.2015
  • Conducted stakeholder interviews to document detailed requirements and acceptance criteria, ensuring alignment with business needs
  • Coordinated and presented UAT deliverables to internal regulatory teams, ensuring systems maintained compliance with 21 CFR Part 820, ISO 14971, and ISO 13485
  • Facilitated user acceptance testing (UAT) and performed regression testing to maintain system integrity and ensure successful UAT sign-offs

Education

Bachelor of Arts - Information Technology in Management

Concordia University
St. Paul, MN

Associate's Degree - Records and Information Management

Chippewa Valley Technical College
Eau Claire, WI

Skills

  • User Acceptance Testing (UAT)
  • Test Case Development
  • Test Plan Creation
  • Defect Analysis & Resolution
  • Test Management Tools
  • Root Cause Analysis
  • HIPAA / 21 CFR Part 820 / ISO 13485
  • Business Requirements Analysis
  • Gap Analysis
  • Process Improvement
  • System Configuration Testing
  • SDLC / Agile Methodologies
  • Cross-functional Collaboration
  • Stakeholder communication
  • Project Management

Certification

  • Certified Scrum Product Owner
  • Root Cause Investigation for CAPA, Weaver Consulting
  • Project Management Foundations
  • Software Testing Foundations, SQE Certification
  • ITIL V3

Timeline

Senior Business Analyst, Consultant

Ecolab
07.2024 - 11.2024

Senior Business Analyst, Consultant

Boston Scientific (formerly Preventice)
07.2023 - 06.2024

Principal IT Software Project Lead

Medtronic
10.2019 - 01.2023

IT Quality Test Team Lead

Medtronic
10.2015 - 09.2019

Business Analyst

Medtronic
10.2006 - 09.2015

Bachelor of Arts - Information Technology in Management

Concordia University

Associate's Degree - Records and Information Management

Chippewa Valley Technical College
LuAnne Cherwinka