Erika Colomb

Experience

1. Systems Engineer 3

   Terumo Blood and Cell Technologies

   Apr 2022 — Present · Lakewood, CO, US

   Lead design change reviews for sustaining products to ensure proper design controls were being followed. These typically lead to updated and/or new product requirements and re-verification activities.* Completed extensive research and documentation of designs that were previously undocumented.* Traveled to customer sites to assess user environments and develop user needs for a new product.* Developed product requirements as they related to user needs, assessed traceability up to user needs and down to lower levels.* Conducted gap assessments for both traceability and risk (dFMEA and uFMEA) for multiple devices and communicated to cross functional teams where gaps existed for future design iterations.* Attended conferences to understand how other, similar products are being used on the market.* Organized and completed a study that resulted in a larger profit for the company by influencing a surgeon to use a bone marrow separation device as opposed to a blood separation device, which is a more expensive TBCT component.

Education

• Rensselaer Polytechnic Institute

  Bachelor’s Degree, Biomedical Engineering, Biomechanics Concentration, Psychology Minor

  2012 — 2016

• Colorado School of Mines

  Master’s Degree, Mechanical Engineering, Biomechanics Research Track

  2016 — 2018

• DTU - Technical University of Denmark

  Study Abroad Semester, Biomechanical Engineering

  2014 — 2014