Director of Quality and Regulatory Affairs and Director of Product Development (Consultant) @ MobileMedTek (July 2012 - December 2018)
Regulatory Expert (Consultant) @ (August 2016 - June 2017)
Executive Partner - Research and Development @ EPIKARDIS MEDICAL, LLC. (March 2014 - May 2017)
Principle Systems Engineer - Global Consumables (Consultant) @ (December 2012 - September 2015)
Executive Partner - Research and Development @ WRISTDOCS, LLC. (October 2014 - February 2015)
Program Director and Program Manager @ MedVenture Technology (July 2010 - November 2012)
Product Development and Quality Consultant @ Aspen Biopharma (January 2009 - September 2012)
Systems Engineer and Technical Project Leader (Contract) @ (April 2006 - July 2010)
Technology Consultant @ (November 2006 - January 2007)
Project Manager and Manufacturing Engineering Manager and Evaluations Manager @ TriVirix / UMM Electronics (October 1999 - April 2006)
Sr. Product Development Engineer, Advanced Fuel Systems @ (January 1994 - October 1999)
Director of Quality Assurance, Regulatory Affairs and Engineering @ For Women By Women (July 2019 - January 2022)
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., MobileMedTek and ORTHOPEDIX. 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 2 emails and 2 mobile phone numbers on RocketReach.
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