Hello! I'm Sarah
I am quality assurance engineer in a global semiconductor company. I took a master degree in Biomedical Engineering and I founded the Bioengineering Commission at the Order of Engineers in Bergamo, Italy, where I live. I am mother of two children and in my spare time marathon runner and triathlete.
Sarah Burgarella
Quality Assurance and Biomedical Engineer
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Email:
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Date of Birth:
December 16th, 1980
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EXPERIENCE
2016 - PRESENT
Quality Assurance Engineer
STMICROELECTRONICS (Milan, Italy)
Quality Assurance Engineer in the "System Research & Applications (SRA)" division of STMicroelectronics (Milan, Italy – www.st.com). Activities:
CONFORMITY EVALUATION OF ELECTRONIC PRODUCTS: verification of the regulatory aspects for the certification of electronic boards developed for the European, American, Canadian and Chinese market. Analysis of local regulations, control of the technical documentation, verification of the requirements on the suppliers, interface with accredited laboratories for tests and with regulatory authorities. Set up of guidelines for the development teams.
CORPORATE QUALITY CERTIFICATION: support for the quality certification (ISO 9001: 2015) of the SRA division, according to the methods established by the company Quality Management System (QMS). Interface as external QA with the project managers of divisional projects for the verification of quality requirements: set up of guidelines and templates for the development teams, support for project documentation management, support for risk management.
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2005-2016
Biomedical System Engineer
STMICROELECTRONICS (Milan, Italy)
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Biomedical System Engineer in the “Advanced System Technology (AST)” division of STMicroelectronics (Milan, Italy – www.st.com). Activities:
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RESEARCH AND DEVELOPMENT of low-cost lab-on-chip devices, to automate the analysis of biological samples in medical diagnostic applications (microfluidic chips for DNA analysis, micro-electromechanical systems -MEMS- for cellular analysis). Activities performed in collaboration with universities and research centers and organized in preliminary studies, numerical simulations and experiments aimed to design complete prototype solutions.
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EVALUATION OF MEDICAL PRODUCT CONFORMITY (IVD) according to the applicable European directives. Preparation and management of technical project documentation, collaboration with accredited test laboratories and notified bodies, organization of internal training courses.
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FUNDED PROJECTS: participation in projects funded by the European Union in the medical devices and in vitro diagnostics area. Preparation and management of project documentation, with particular regards to market analysis and international certification.
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2009 - present
Founder and member
COMMISSION ON BIOENGINEERING - Order of Engineers (Bergamo, Italy)
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I founded the Bioengineering Commission at the Order of Engineers in Bergamo, Italy, with the objective to gather professionals from several areas of activities (basic research, medical devices, clinical management) and to disseminate the knowledge on Bioengineering, through the promotion of relations between universities, research centers, industries and institutions.
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I realize custom projects in Bioengineering upon request, in the fields of health, environment and sport.
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Here is the collection of my "Special Projects" in Bioengineering
EDUCATION
2008
National Engineering Examination
ORDER OF ENGINEERS (Bergamo, Italy)
Italian Engineering Examination, required to become a Professional Engineer in Italy. Admission to the Order of Engineers of Bergamo, Italy (Registration Number 3516, Section A).
1999-2005
Master's Degree
"POLITECNICO DI MILANO" UNIVERSITY (Milan, Italy)
Master degree in Biomedical Engineering, Politecnico di Milano University (Milan, Italy), 100/100 cum laude. Thesis: “Design and development of a dedicated system for the acquisition and the analysis of images from DNA chip”. The project was developed at STMicroelectronics. Advisor: Prof. Antonio Pedotti.
1994-1999
High School Diploma
“LICEO SCIENTIFICO F. LUSSANA” HIGH SCHOOL (Bergamo, Italy)
High school diploma with full marks (100/100) at Science High School “Liceo Scientifico F. Lussana”, Bergamo, Italy.
LINKS
SKILLS AND LANGUAGES
Microsoft Office
Company softwares: Document Management System tool, Project Management tool, FMEA tool
Web Design
Italian - mother tongue
English - view level
Spanish - view level
EXPERTISE
OVERVIEW
I am good at:
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critical thinking: analysis and synthesis of complex problems leading to simple solutions;
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exposing technical issues to both professional and lay audience.
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PRODUCT CONFORMITY ASSESSMENT
To ensure that products meet the requirements set by regulatory authority in the importing country. Analysis of local regulations, control of the technical documentation, interface with regulatory authorities and with accredited laboratories for testing. For medical products (experience: 2012-2016) and electronic products (experience: 2016 - present).
CERTIFICATION OF THE QUALITY MANAGEMENT SYSTEM
Support for the quality certification (ISO 9001: 2015) of the company division, according to the methods established by the company quality management system. Support for project documentation management and for risk management (Failure Mode and Effects Analysis). Experience: 2016 - present.
RESEARCH
Collaboration with universities and research centers. Preliminary studies, numerical simulations and experiments to design complete prototype solutions. Writing of research proposals and scientific articles. Presenting at scientific meetings. Experience: 2005-2016 continuously; 2016 - present, for special projects upon request.
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ENDURANCE SPORT
Marathon runner since 2008, triathlete since 2014 (preferred distance: Ironman 70.3). The challenge in marathon and triathlon (open water swimming, cycling and running) is the competition between you and the course, but primarily between you and your mind. Success in these endurance sports is all about the mental ability to handle the fatigue, the ability to master the limits that you think you have.