Ana P. V. Glass, D.O. Email & Phone Number

Salem, Virginia, United States

Redmond And Issaquah, Washington, United States

Redmond, WA

Redmond, WA

• Support design and development projects by:
• Leading activities related to risk analysis including Preliminary Risk Assessments (PHA) and Design Failure Mode and Effect Analysis (DFMEA)
• Coordinating supplier sourcing, risk analysis, qualification, and selection
• Developing and maintaining Design History Files
• Providing input on compliance with the Quality System and the Product Development Process
• Reviewing and approving product specifications, drawings, and inspection methods

• Performed audits on companywide quality procedures for compliance with ISO and EN ISO 13485, FDA 21 CFR Part 820 QSR, EU 93/42/EEC MDD, SOR/98-282 CMDR, and other regional and international regulations and standards
• Created roadmaps to compliance for novice devices and collaborated with product development and manufacturing engineers to assure product and manufacturing designs are in conformance with the quality management system.
• Coordinated with NRTLs and organized materials for testing per IEC 60601-1 3.1rd Edition among other standards
• Reviewed engineering change orders
• Investigated complaints and CAPAs, performed root cause analysis, and created plans for implementation
• Conducted and updated risk/benefit analysis for a wide range of medical devices per ISO 14971

West Lafayette, IN

• Improved an archiving system of regulatory submissions
• Designed a system using Microsoft Excel macros that captured current documentation requirements for registrations of Medical Devices in 45 countries in a user-friendly format that will be used as a method of training.
• Developed an efficient system that captures and maintains detailed information from the approvals in each country to improve accuracy of submissions
• Implemented a regulatory approvals tracking system that improved marketing efficiency
• Created departmental procedures to improve productivity and quality of regulatory processes
• Prepared regulatory documents for review and submission

• Designing biogas digester system for community in Uganda
• Design lead for the educational team, in charge of educating community of digester design and safety

• Camp Riley Sailboat Team *Design Lead *EPICS AMD Design Award
• Lead a multidisciplinary team of undergraduate students to develop a mechanism that will allow a sailboat to be controlled using a sip-and-puff switch
• Developed two mechanical designs and tested them
• Coded an Arduino microcontroller to transform the electric input into the mechanical output needed for the sailboatGreater Lafayette Special Services (GLASS) Team *Design Lead
• Designed interface for HEARD (Handheld Educational Augmentative RFID Device) project, worked close with stakeholders and users to create a design for the device casing oDesigned in AutoCAD and SolidWorks to make a case.
• Lead the CATCH (catching and throwing system) team to create two systems to improve how students with disabilities interact in their physical education classes oSuccessfully delivered a handheld catching system that.

• mentored incoming freshman engineering students

Doctor Of Osteopathic Medicine

Bachelor Of Science (Bs), Bioengineering And Biomedical Engineering