2019 -2022 Director of Quality Assurance, Regulatory Affairs and Engineering @ For Women By Women
2012 -2018 Director of Quality and Regulatory Affairs and Director of Product Development (Consultant) @ MobileMedTek
2016 -2017 Regulatory Expert (Consultant) @
2014 -2017 Executive Partner - Research and Development @ EPIKARDIS MEDICAL, LLC.
2012 -2015 Principle Systems Engineer - Global Consumables (Consultant) @
2014 -2015 Executive Partner - Research and Development @ WRISTDOCS, LLC.
2010 -2012 Program Director and Program Manager @ MedVenture Technology
2009 -2012 Product Development and Quality Consultant @ Aspen Biopharma
2006 -2010 Systems Engineer and Technical Project Leader (Contract) @
2006 -2007 Technology Consultant @
1999 -2006 Project Manager and Manufacturing Engineering Manager and Evaluations Manager @ TriVirix / UMM Electronics
1994 -1999 Sr. Product Development Engineer, Advanced Fuel Systems @
David Dlugo Education
University of Wisconsin-Madison 1993-1995
David Dlugo Skills
Specifications
Technical Writing
Systems Engineering
Project Management
FMEA
Product Management
Lean Manufacturing
GMP
Manufacturing
ISO 13485
Product Development
FDA
Quality Assurance
Program Management
Testing
Engineering
Medical Devices
Engineering Management
Quality System
Proposal Writing
Investor Relations Support
Early-stage Startups
Mechanical Engineering
Cross-functional Team Leadership
Risk Management
R&D
Strategy
CAPA
21 CFR 820
Use Cases
Competitive Analysis
Requirements Management
BPMN
Brainstorming Facilitation
Hazard Analysis
Poka Yoke
DFX
Project Remediation
Remediation Engineering
Validation
Root Cause Analysis
DMAIC
SPC
Process Improvements
Design of Experiments
Six Sigma
Design Control
Design for Manufacturing
Management
V&V
David Dlugo Summary
David Dlugo, based in Florida, United States, is currently a Senior Director of Quality at Kymanox. David Dlugo brings experience from previous roles at Rx Bandz, Supernus Pharmaceuticals, Inc., For Women By Women and MobileMedTek. David Dlugo holds a 1993 - 1995 University of Wisconsin-Madison. With a robust skill set that includes Specifications, Technical Writing, Systems Engineering, Project Management, FMEA and more. David Dlugo has 1 emails and 2 mobile phone numbers on RocketReach.
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