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Christopher
cwjohnsonc@gmail.com
904-625-6200
1269 Cutlass Road
Orange Park, FL 32065
Engineering Technician
4 years experience W2
0
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Average rating
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Summary

Skillset/Knowledge

  • Excel: Pivot Tables, VLookUp, CountIf, Sums
  • Data Entry
  • Documentation Skills
  • Analytical Skills
  • Knowledge of Regulatory Requirements for distribution in the EU.
  • Knowledge of FDA 21 CFR regulations
  • Quality Systems
  • Lifecycle testing experience
  • Test report writing
  • CAD experience with Autodesk (Fusion 360), and Solid Edge in the professional environment.

Undergraduate Coursework: Physics, Chemistry, Biology, Microbiology, Molecular biology, Medical Terminology and Genetics

Personal Statement: Excellent interpersonal skill that help me work in any given team environment. Will take leadership of issues in order to drive solution oriented thinking.

Interests: Car enthusiast, gaming enthusiast, dog enthusiast, basketball enthusiast, people lover.

Experience
Engineering Technician
Medical Devices
Jun 2018 - present

  • Creation of Risk Management Reports
  • Strong understanding of Post Market Surveillance activities
  • Creation of Complaint Reports
  • Calculation of occurrence rates for failures pertaining to implantable products and instruments by consulting existing risk documentation such as an aFMEA and dFMEA.
  • Lifecycle testing
  • Test report writing.
  • Update print drawing using SolidEdge
  • Device Description drafts
  • Aid in the creation of Clinical Evaluation Reports
    • Remediation Project- Retrospective project to up design history files to current compliant standards called forth by the FDA for implants and instruments within a certain class.
    • Post Market Surveillance Project- Ownership and completion of this project in order to fulfil necessary risk documentation for regulatory criteria.
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Quality Analyst I
Nov 2017 - May 2018
Vision
  • Use of various test methods to ensure correct product specification within the laboratory using a wide variety of scientific instruments
  • Parametric testing of product using transducers
  • Further physical characteristic inspection with the use of interferometer
  • Follow Process Control within the laboratory
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Non-cloudteam Skill
Education
Bachelor's in Biomedical Sciences
Florida State College at Jacksonville 2017
Skills