Barbara Baldi Email & Phone Number

Roseville, Ca, Us

Roseville, Ca, Us

Rocklin, California, United States

Sacramento, California, United States

Sacramento, California Area

Erlangen Und Umgebung, Deutschland

* Responsible for managing a summative usability study for a medical device (transcutaneous vagus nerve stimulator)* Set up use cases and test scenarios as well as workflows for validation testing* Support of a 510(k) submission with the FDA * Was responsible for formative handling studies for a medical device (transcutaneous vagus nerve stimulator) in accordance with IEC 62366 - The formative studies included testing the materials used for the device, the device´s haptical properties, its design and functionality, as well as its user interface - The outcomes of these studies had impact on the device´s risk management, design, packaging, and labelling* Collect, organize, synthesize, and analyze data; summarize findings; develop conclusions and recommendations for product improvement and marketability* Technical documentation in precise compliance with 21 CFR Part 820 and European Notified Bodies (e. g. Design History File, Design Validatin Plan, Usability Engineering File)

Erlangen Und Umgebung, Deutschland

* Experienced insight into the departments of Research and Development, Manufacturing and Marketing, Risk Assessment, and Quality Management* Technical documentation in compliance with 21 CFR Part 820

Ansbach, Germany

* Delegated tasks and managed a team of assistants, including employee scheduling * Trained new personnel and apprentices* Assisted in dental and oral surgical procedures: - Preserving and sustaining care - Prosthetic care - Surgical care such as surgical removals of teeth, root amputations, insertion of implants* Performed professional oral cleaning* Interacted with patients in and out of the operating room* Responsible for meeting hygienic and sanitary standards such as disinfecting and cleaning dental and surgical devices and accessories* Managed appointments* Experience with working in sterile environment*Managed material and devices purchasing

Bachelor Of Engineering (B.Eng.), Biomedical/Medical Engineering

In Biomedical Engineering at the University of Applied Sciences in Ansbach, students learn to design equipment, systems or software.

Bachelor Of Engineering (B.E.), Biomedical Engineering