Nickea Champegnie                                                                                               

Associate Engineer                         

Nickea has 3 years hands-on experience with validation, medical instrumentation, and research within the pharmaceutical and medical device manufacturing industries. She has experience with biologics, safety, and regulatory issues as well as product and experimental design. 

EXPERIENCE...        

• Developed and executed qualifications (IQ, OQ, & PQ) for equipment, utilities, and facilities for pharmaceutical and medical device companies (Cardinal, Noven, Cordis, Beckman Coulter).
• Worked with a medical device Quality Assurance Team to perform failure analysis of non-conforming product including balloon catheters and stents.
• Implemented and executed a formal medical device training program for technicians. Benchmarketed several companies to achieve best results and designed program to meet the company requirements. Responsible for organizing training material for each individual technician utilizing database tracking system.
• Performed research on the decontamination of used balloon catheters and stents to identify potential for re-use.
• Designed a bioreactor for stem cell research including construction of computerized image design, worked with team to modify/enhance/finalize design layout, and developed the procedures for assembly.
• Conducted calibration techniques for continual media flow bioreactor device using permeability calculations in agarose gel in order to determine cell differentiation and chondrogenesis during actual experimentation.
• Developed a method to perform islet cell transplant analysis using calorimetric –voltage instrumentation. Used insulated gold plated chambers to culture islet cell and to measure the electrical conductivity to determine the performance of transplant tissue.

POSITIONS HELD...

• Associate Engineer                                    BioTeknica
• Quality / Engineering Services Intern         Cordis, Johnson & Johnson
• Research Assistant                                   Department of Biomedical Engineering, UM
• Lab Assistant                                             Diabetes Research Institute, UM School of Medicine 

EDUCATION...

• B.S. Biomedical Engineering                       University of Miami