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Steve Shane Location
Saint Paul, MN, US
Steve Shane Work
Vice President of Operations and Program Execution @ (August 2025 - Present)
Head of Minnesota Sites and Program Director @ (February 2023 - September 2025)
Program Director and Head of Plymouth Site @ (July 2021 - February 2023)
Senior Program Manager @ (September 2018 - June 2021)
Program Manager @ (July 2016 - September 2018)
President @ Steve Shane Consulting (July 2016 - September 2018)
Program Manager @ (March 2014 - January 2016)
Project Manager @ (July 2012 - March 2014)
Project Leader @ (December 2009 - July 2012)
Sr Engineer @ (February 2005 - December 2009)
Steve Shane Education
Northwestern University - Kellogg School of Management
MBA (Entrepreneurship, Strategy, Healthcare Enterprise Management)
2011-2014
Purdue University
Bachelor of Science (BS) (Mechanical Engineering)
1999-2004
Steve Shane Skills
21 CFR Part 11
Business Process Improvement
Business Strategy
CAPA
Change Control
Competitive Analysis
Consulting
Corrective and Preventive Action (CAPA)
Cost Benefit Analysis
Cross-functional Team Leadership
Culture Change
DFSS
DMAIC
Design Control
Engineering
FDA
FMEA
Failure Mode and Effects Analysis (FMEA)
GMP
General Management
Healthcare Consulting
ISO 13485
Leadership
Lean Operations
Management
Manufacturing
Medical Device R&D
Medical Devices
Minitab
Pharmaceutical Industry
Portfolio Management
Process Improvement
Product Development
Product Management
Program Management
Project Management
Quality Management
Quality System
R&D
Research and Development (R&D)
Risk Management
Root Cause Analysis
Six Sigma
Start-ups
Strategic Planning
Strategy
U.S. Food and Drug Administration (FDA)
User Research
V&V
Validation
Vendor Management
Verification and Validation (V&V)
Voice of the Customer
Verification and Validation V&V
Start Ups
Corrective and Preventive Action Capa
Research and Development R&d
Cross Functional Team Leadership
u.s. Food and Drug Administration Fda
Failure Mode and Effects Analysis Fmea
u.s. Food and Drug Administration
Corrective and Preventive Action
Failure Mode and Effects Analysis
Research and Development
Verification and Validation
Steve Shane Summary
Steve Shane, based in Saint Paul, MN, US, is currently a Vice President of Operations and Program Execution at Elastro. Steve Shane brings experience from previous roles at Veranex, Ximedica and EdgeOne Medical. Steve Shane holds a 2011 - 2014 MBA in Entrepreneurship, Strategy, Healthcare Enterprise Management @ Northwestern University - Kellogg School of Management. With a robust skill set that includes 21 CFR Part 11, Business Process Improvement, Business Strategy, CAPA, Change Control and more. Steve Shane has 4 emails on RocketReach.
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