Dan Wellington's Location
Macedon, New York, United States, United States
Dan Wellington's Contact Details
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About Dan Wellington
Dan Wellington is a Owner of my Third Act at Retired from 4D Concepts at Retired from 4D Concepts. He possess expertise in fda, v&v, product development, design control, quality management and 40 more skills.
Dan Wellington's Current Company Details
Retired From 4D Concepts
Owner of my Third Act at Retired from 4D Concepts
Dan Wellington Work Experience Details
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Owner Of My Third ActRetired From 4D Concepts Jan 2021 - PresentIt was a wonderful 46 years as a engineer, with the last 40 years spent in the outstanding field of medical devices, however it is time to enjoy life a different way. I will miss the people but am excited to spend time with my family and friends. Happy Trails to all!
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Principal Consultant4D Concepts Jan 2016 - Dec 2020Macedon, NyProvide technical & business consulting solutions for medical device quality, manufacturing and design issues. Specializing in Design Control and Risk Management. Current contract working with a large pharma company implementing 21 CFR Part 4 combination products specifically Subpart B Postmarketing Safety Reporting. Previous long term contract was with a laparoscopic company remediating their Design History files and Risk Management Files as well as major revision to their QMS relative to Design Controls.
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Engineering SpecialistBaxter International Inc. Jul 2014 - Dec 2015Medina, NyCorporate R&D and Device Engineering specializing in electromechanical medical product Risk Management -
Sr. Manager QualityBaxter International Inc. Apr 2012 - Jul 2014Medina, NyResponsible for the Risk Management Quality Engineering team. Lead a team of about fifteen Quality Engineers and consultants responsible for the Design History File, Software Design Assurance and overall Risk Management aspect of a significant 510(k) submission for an IV infusion pump. Product Quality lead in the Medina facility.
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Director, Technical ProjectsSigma International General Medical Apparatus, Llc. Mar 2011 - Sep 2012Medina, NyServed as a resource to; the Engineering group relative to Design Controls, specific design problems, Failure Investigation mentor and Project Management, the Quality group on Quality Systems and operational quality issues including MDR resolution and Risk Management, and the Regulatory group regarding 510(k) strategy and submission.
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Vice President, EngineeringSigma International General Medical Apparatus, Llc. Nov 2010 - Mar 2011Medina, NyManagement of all engineering functions including software, hardware and mechanical aspects for the Spectrum Infusion pump system including a major software release for both the pump and Master Drug Library (MDL).
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Director, Quality And Regulatory AffairsSigma International General Medical Apparatus, Llc. Apr 2010 - Jan 2011Medina, NyManagement of Quality Assurance group composed of twenty employees at this infusion system design and manufacturing facility. Infusion system is comprised of a pump, the MDL, and the Gateway server that distributes the MDL to the pumps within the hospital environment. Management Representative for the company. Reported to the CEO and participated on senior management team regarding strategic, as well as tactical, decisions.
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Director, Quality AssuranceWelch Allyn Apr 2007 - Apr 2010Skaneateles, NyCorporate QA Director for the facilities in Skaneateles NY, Beaverton, Oregon and Tijuana, Mexico. Responsible for Quality Assurance related to R&D, Current Product Engineering, Operations, Supplier Management, Quality Systems and overall Document Management. -
Principal4D Concepts Sep 2003 - Apr 2007Rochester, NyProvide technical & business consulting solutions for medical device Quality, Manufacturing and Design issues.
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Vp Product DevelopmentRenal Solutions Jan 2001 - Aug 2003Rochester, NyRecruited and managed an international team that designed, developed and contract manufactured a Home Hemodialysis system utilizing software driven electromechanical equipment, sterile and non-sterile disposables.
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Vp Product DevelopmentHemocleanse Jul 1998 - Jun 2000Rochester, NyManaged the manufacturing operation for the disposables associated with the BioLogic DT, a drug overdose & liver dialysis system.
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PresidentWellport, Inc. Mar 1992 - Jul 1998Rochester NyCo-founded and managed all aspects of company activities, including corporate legal liaison. Company was a Medical Device contract Design and manufacturing organization. Set up and maintained Class 100,000 clean rooms and manufactured Class II Critical and Class III devices, employing both hand and semi automated assembly, in this environment.
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Vice President, TechnologyBiosurge, Inc. Nov 1987 - Jan 1990Rochester, NyManaged the team that moved a sterile disposable intraoperative autotransfuser from concept design through to market introduction within a venture capital funded environment. Product was noted as one of R&D Magazine “Top 100”Products for 1990.
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Engineering ManagerCobe Cardiovascular Feb 1980 - Dec 1986Lakewood, CoManaged the Continuing Engineering department during the design and manufacturing transfer of a disposable membrane oxygenator (COBE Membrane Lung (CML)) used during open heart surgery.
Dan Wellington Skills
Fda
V&v
Product Development
Design Control
Quality Management
Manufacturing
Engineering
Medical Devices
Quality Assurance
Project Management
Validation
Capa
Quality System
Iso 13485
R&d
Risk Management
Regulatory Affairs
Iso 14971
Six Sigma
Medical Device Consulting
Design Of Experiments
Dmaic
Fmea
Cross Functional Team Leadership
Iso
Quality Auditing
Spc
Gmp
Root Cause Analysis
Quality Control
Verification And Validation
Failure Mode And Effects Analysis
Process Validation
Consulting
Design For Manufacturing
Testing
21 Cfr Part 11
Lean Manufacturing
Continuous Improvement
Change Control
Process Simulation
Supplier Quality
U.s. Food And Drug Administration
Iso Standards
Research And Development
Dan Wellington Education Details
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Mechanical Engineering -
University Of PhoenixProject Management
Frequently Asked Questions about Dan Wellington
What company does Dan Wellington work for?
Dan Wellington works for Retired From 4d Concepts
What is Dan Wellington's role at the current company?
Dan Wellington's current role is Owner of my Third Act at Retired from 4D Concepts.
What is Dan Wellington's email address?
Dan Wellington's email address is da****@****ail.com
What is Dan Wellington's direct phone number?
Dan Wellington's direct phone number is +158539*****
What schools did Dan Wellington attend?
Dan Wellington attended Clarkson University, University Of Phoenix.
What skills is Dan Wellington known for?
Dan Wellington has skills like Fda, V&v, Product Development, Design Control, Quality Management, Manufacturing, Engineering, Medical Devices, Quality Assurance, Project Management, Validation, Capa.
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Dan Wellington
Retired Antitrust Partner At Norton Rose Fulbright Us LlpWashington Dc-Baltimore Area4fulbright.com, fubright.com, nortonrosefulbright.com, nortonrosefulbright.com
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