Mackenzie Nermyr Email & Phone Number

Minneapolis, Mn, Us

Brooklyn Park, Minnesota, United States

Mounds View, Minnesota

Strong technical communicator responsible for leading reliability and risk assessments leveraging complaint and testing data within the Medical Device, and specifically the Left Ventricular Assist Device, industry. My role focuses on capturing and summarizing technical information to share status reports, investigation summaries, product and patient risk assessments and more with worldwide regulators who monitor medical device performance. In addition to management of regulatory communications, I am responsible for - contributing to and/or leading CAPA investigations- conducting risk assessment and analyses, generating FMEA and residual risk evaluations- statistical analysis of risk associated with field issues / design tests / manufacturing processes- creating and integrating procedures to better establish risk evaluation and assessment processes- conducting product and patient hazard risk analyses to inform recommendations or actions to take

Mounds View, Minnesota, United States

Mounds View, Minnesota

Mounds View, Minnesota

Mechanical Engineer in the Cardiac Rhythm and Heart Failure Business Unit- Developed, operated, and collated bench test methodology and data for characterizing cardiac tissue mechanics- Assisted senior mechanical engineers in prototyping and testing design concepts- Consulted with physicians and key opinion leaders to gain feedback on design concepts and assist in procedural development

Nicaragua

- Trained in Spanish Language, Biomedical Instrumentation, and Equipment found in the Developing World to prepare for full time work in a community hospital in Nicaragua- Worked with local partners to volunteer in hospitals and nearby community organizations as well as receive personalized language training- Repaired and installed new, used, and donated medical equipment at a partner hospital in Chinandega, Nicaragua- Trained hospital staff on proper equipment use and maintenance- Collaborated with international medical agencies to inventory equipment and identify problem areas within several area hospitals

University Of Minnesota, Twin Cities

- Segment, post-process, and print 3D models and devices for medical research, clinical devices, and surgical simulation - Educate and train new volunteers and networking contacts through various conferences and events- Assist in hosting and instructing 3D Printing & Segmentation Workshops for interested students