I approach a class with structure and flexibility to meet the students needs. I use visual teaching methods when applicable and interactive techniques that allow the student to practice their spanish. I care about making learning fun and making a difference so that they may use the skills they learn to benefit their future.
I have a degree in Chemical Engineering and minor in Spanish studies. I am fluent in Spanish and have completed a year abroad to learn in Spain to further understand the culture and language. I have professional experience in spanish.
University of Toronto, Toronto, Ontario November 2019
Master of Engineering in Biomedical Engineering
Andrews University, Berrien Springs, Michigan August 2018
Bachelor of Science in Engineering w/ emphasis in Chemical, Spanish Studies Minor
Regulatory/Quality Affairs - Volunteer June 2020 - Present
Springborne Life Sciences
• Assist with preparing 510(k) FDA submission documentation for Class II medical device.
• Review and prepare submission content to ensure applicable regulatory and quality compliance.
Medical Maker -Volunteer January 2020 - Present
3D4MD Medical Makers
• Assist with FDA and Health Canada submission requirements under Emergency Use Authorizations for PPE for healthcare providers.
• Assist with face shield product development.
• Assist with implementing quality management system and compiling documents using Matrix QMS software to ensure regulatory and quality compliance including ISO 13485, Health Canada, FDA and EU regulations.
Regulatory Affairs Intern May 2019 – September 2019
Pharmalex, Madrid, Spain
• Assisted with the preparation of technical dossiers, internal procedures and QMS documentation, and coordinating compliance documentation to meet medical device regulations.
• Assisted with compiling, reviewing and submitting documentation to AEMPS for registration of medical device manufacturing license to meet essential requirements according to MDR 2017:745.
• Appraised research material to assess the usefulness, validity and methodological features for clinical studies and proof of concept and attended meetings for clinical evaluation study requirements
• Reviewed marketing materials for deficiencies and to ensure they comply with European requirements.
• Given medical device product information, identified classification and main requirements including principles of ISO 13485 and ISO 14971 for the registration of a medical device.
• Assisted in a mock audit for clients undergoing preparation for medical device manufacturing license.
Research Assistant August 2016 - May 2017
Department of Engineering and Computer Science
Andrews University, Berrien Springs, MI
• Collected, captured and analyzed data for Electrochemiluminescence (ECL)-Biosensor to determine best suitable solution concentration.
• Investigated methods to develop a compatible, affordable and user-friendly device that would permit the biosensor to be available to a larger range of users.
• Tested multiple Ruthenium complex solution concentrations to obtain the optimal range that can be analyzed with a mobile device.
Medical Device Development for Insulin Pump January 2019 – April 2019
• Collaborated closely with a team of 4 graduate students to develop an optimized insulin pump design that mitigates human factor errors and creates a more user-friendly device.
• Applied ISO and IEC regulatory requirements and medical device standards including ISO 13485, ISO14971 and IEC 62304 through concept and planning phase of design controls.
• Responsible for organizing and conducting professional interviews with diabetes users, research directors, and human factors specialists.
Design of Medical Device for Cautery Pen January 2019 – April 2019
• Collaborated closely with multi-disciplinary group including biomedical engineers, mechanical engineers and physicians.
• Analyzed the usability of the medical device and investigated cause of errors to compile risk assessment and apply human factors standards.
• Implemented Failure Modes and Effects Analysis (FMEA) to assess and mitigate unacceptable risks through proposed improvements to ergonomics of an existing design.
Optimization of Bone Anchored Hearing Aid Device September 2018 – December 2018
• Worked effectively within a five-person team to design a better equipped hearing aid to meet customer needs for more durable hearing aids.
• Implemented an expulsion mechanism to protect internal circuitry components of the BAHA from contamination and susceptibility to damage.
• Arranged meetings with key opinion leaders (surgeons, audiologists, and hearing instrument specialists) for feedback on user needs.
Mobile Phone Based ECL Instrumentation August 2017 – April 2018
• Developed a compact, affordable and user-friendly alternative to electrochemiluminescence instrumentation that allows users to capture and analyze various concentrations of solution.
• Documented specifications and operational procedures by developing a user manual.
• Implemented the device as a learning tool for feedback and performance evaluation.
Proficient in Microsoft Office
Leadership, Teamwork, Project Management
SolidWorks, Fusion360, Matrix QMS
Language: Fluent Spanish/English
Biomedical Product Development, Clinical Engineering Surgery/Instrumentation, Applying Human Factors to the Design of Medical Devices, Cognitive and Psychological Foundations of Effective Leadership, Regenerative Medicine, Biomaterials Science
(URS) Research Scholarship August 2016
Andrews University Engineering/Technology Endowed Scholarship September 2017
Engineering Excellence Award April 2018
|at their home||at your home||By webcam|
|1 hour||Not available||Not available||$25|