Science Learning Institute
Biomedical Devices Certificate and Courses
Looking for a new career?
Learn high-demand skills in fun, hands-on classes in Biomedical Devices. No previous experience necessary!
Take Biomedical Engineering courses in our certificate program to learn about the problems biomedical engineers solve, including designing and manufacturing.
Fall registration now open. Classes start September 25. Apply today
Ever thought you could create something exciting that might change lives?
Certificate of Proficiency
(24 Units) [Non-Transcriptable]
This certificate program prepares you for high-demand positions in this fast growing industry, and offers internship opportunities at companies and research institutions in Silicon Valley.
ENGR 83A Introduction to Biomedical Engineering (5 units)
ENGR 83B Design & Manufacturing in the Biomedical Engineering Field (5 units)
ENGR 83C Introduction to Medical Device Regulations (5 units)
ENGR 83D Introduction to Quality Assurance (5 units)
ENGR 6 Engineering Graphics (4 units)
Engr 83A: Introduction to Biomedical Engineering (5 units) Fall 2017
Fall Quarter 2017
|20700||ENGR-083A-01||Lecture||06:30-08:45 PM||TTh||NIKOLAC, FRED||4716|
In this class, the students are introduced to a wide variety of problems that biomedical engineers solve.
It covers variety of applications, such as, implantable devices, bioinstrumentation, and biomaterials. It provides general understanding of the biomedical device industry in terms of its size and scope, current trends, and the wide range of products involved with emphasis on biomedical companies in California.
It also provides an overview of the development of a medical device from initial conception through development, testing, validation, manufacture, clinical trials and final approval by regulatory agencies.
Students also work on a final project that involves developing a hand splint for young individuals with disabilities. At the end of the quarter, students present their prototypes. The prototypes are developed using various technologies and materials, including 3D printers, neoprene, silicone rubber, and light metals.
Additionally, the class receives a number of guest lectures from the industry. Past guest speakers have included:
- Keith Sardo, Hanger Clinic
- Catherine Draper, Professional Dental Hygienist
- Karen Minic, California Childrens' Services
- Jeff Draper, Biomedical Engineer
Engr 6: Engineering Graphics (5 units) Fall 2017
Offered Every Quarter, including Fall 2017
The application of orthographic projection to detail and assembly drawings, with examples from various engineering fields. Geometric construction, sketching, dimensioning for interchangeable assembly and specification of materials.
Graphical analysis, documentation and presentation of engineering information. Theory of orthographic projection and its application to graphical solution of the more advanced three-dimensional space problems.
Investigation of relationships between points, lines, planes and solids. Use of solid modeling computer program in carrying out the above course components.
Engr 83B: Design & Manufacturing in the Biomedical Engineering Field (5 units) Winter 2018
An introduction to the design and manufacturing of medical devices with special focus on the unique design manufacturing challenges which are necessary to achieve World Class Manufacturing excellence. Describes the fundamental systems used in the design, development, and manufacturing of medical devices and how they relate to industry regulations.
Specific topics include: material and process selection considerations, aseptic processes, clean-room techniques, sterilization processes, clinical testing, lot traceability, introduction to automation and control systems, testing and instrumentation lab and manufacturing controls.
Engr 83C: Introduction to Medical Device Regulations (5 units) Winter 2018
In this class, the students were introduced to medical device regulations, certification standards, and the agencies involved in the regulatory processes specific to the medical device industry. Topics include Food and Drug Administration regulations, worldwide medical device regulations, and domestic and international standards that apply to medical devices. Students are also introduced to regulatory processes, Good Manufacturing Practices, Good Laboratory Practices, and Good Clinical Practices.
Engr 83D: Introduction to Quality Assurance (5 units) Spring 2018
ENGR 83D is Introduction to Quality Assurance, but what it's really about is Medical Device Quality Systems. In this class, students gained an in-depth understanding of the role quality plays in an industrial environment regulated by the Food and Drug Administration (FDA). This includes the responsibilities of quality assurance during the engineering, manufacturing, and production of a product.
Topics included management responsibilities; design control; production and process controls; software documentation; and servicing. Subjects discussed include applicable ISO standards and FDA regulations. Students were exposed to tools used for process validation and root-cause analysis, and made use of those tools in analyzing real-world medical device recalls.
Media Coverage of Our Program
Los Altos Town Crier, September 6, 2017
KPIX CBS News, December 17, 2016
San Jose Mercury News, January 10, 2016