Jaime Tiesma-Davis Email & Phone Number

Grand Rapids, Michigan, United States

Morrisville, North Carolina, United States

- Manage a team of engineers to perform quality and regulatory consulting activities for medical device and combination product companies.- Lead US regulatory submissions, including: 510(k), de novo, IDE, and Q-Submissions.- Interpret regulations and guidance documents provided by Regulatory Authorities (RAs). - Develop regulatory strategies for medical.

Morrisville, North Carolina, United States

- Perform Risk Assessments and Use-Related Risk Assessments following ISO 14971:2019 methodologies.- Record, investigate, and resolve protocol Deviations, unexpected results, Corrective and Preventive Actions (CAPAs), Complaints, and Medical Device Reports (MDRs). - Author, review, and implement Quality Management System (QMS) Standard Operating Procedures.

Greater Detroit Area

- Took on 10-15 hours of work per week during the academic school year- Managed maintenance and upkeep of Low-Pressure Chemical Vapor Deposition (LPCVD) tempress clean room furnaces for a class 1,000 Clean Room utilized by university and industry researchers nationwide- Collected data from test runs of equipment and adjusted parameters of LPCVD furnaces.

Greater Detroit Area

- Analyzed impact on arterial flow for patients with pulmonary arterial hypertension versus those without- Examined data retrieved from MRI images using VMTK Lab (3D imaging software) to come to conclusions referencing arterial wall constriction and dilation- Solved differential equations relating arterial flow to surface area of arteries