James Dawson

Experience

• 

  City of Bloomington, IN

  May 2017 - Aug 2017

  Process Analysis Intern

  • Analyzed water quality data for the carcinogens TTH and HAA5 using Microsoft Excel, which was published on the city governments website• Studied water purification methods and how they may create carcinogens• Digitized data for public release to demonstrate the safety of the tap water

• 

  City of Bloomington, IN

  May 2018 - Aug 2018

  Plant Data Entry and Evaluation Internship

  • Researched State and Local laws of what documents were required to be stored, which increased efficiency• Disposed of unnecessary documents allowing an additional office to be usable• Assisted Customer Service in accepting and labeling water samples for onsite lab testing• Helped customers and contractors on what services we offered and at what prices• Completed a training course on VBA to assist digitization of paperwork

• 

  Modis

  Nov 2021 - Mar 2024

  Sustaining Engineer

  • Conducted Gap Analysis mapping out where projects fall short of EU MDR (European Union Medical Device Regulation 2017) compliance and internal guidance.• Led EU MDR labeling compliance efforts for medical devices on up to twelve projects concurrently.• Led cross functional stake holder review meetings.• Interfaced regularly with Product Management, Regulatory Affairs, Clinical Affairs, Quality Engineering, Quality Assurance, and Medical Affairs.• Created new Instructions for Use (IFUs) and Patient Facing Information (PFIs) when they did not previously exist.• Implemented required updates to current IFUs, PFIs, and device labels.• Successfully facilitated discussions that created a new standard label format for all horizontal labels, meeting EU MDR Requirements and avoiding impact on multiple departments. • Led discussions and an analysis of alternatives, including cost comparison, when the required IFU size would not fit on the current packaging.• Designated as the sole labeling project lead for Reproductive Health after nine months, while continuing work on other projects.• Took on sustaining project lead role, overseeing the Design Input Requirements, Hazard Analysis, Usability and Design Failure Mode and Effect Analysis, Biological Evaluation Procedure and Report, and Technical Analysis in addition to my other responsibilities.• Made and supported a technical file to organize important information in a searchable format, which assisted department goals and increased communication. Show less

• 

  Indiana Department of Environmental Management

  Nov 2024 - now

  Environmental Engineer 2

  Reviewing Air Quality Permit applications with the Indiana Department of Environmental Management.