Alex Omiatek

Alex Omiatek currently serves as a Quality Engineer at EdgeOne Medical, where he plays a pivotal role in advancing the company's commitment to delivering safe, reliable, and compliant medical devices. In this capacity, Alex leads comprehensive design verification and validation (DV&V) studies, ensuring that all products meet stringent regulatory standards such as ISO 13485 and FDA requirements. His expertise in study oversight and test system design allows him to develop innovative test methods and fixtures that enhance the accuracy and reliability of validation processes. By authoring detailed test protocols and reports, Alex ensures transparent documentation and facilitates seamless communication with regulatory bodies and clients.

A key aspect of Alex’s role involves acting as the primary liaison with clients, managing study execution, and developing test strategies tailored to complex medical device projects. His hands-on approach and strong interpersonal skills foster collaborative relationships, enabling cross-functional teams to work efficiently and effectively. Alex’s proficiency in CAD and MATLAB supports the design and analysis of test systems, optimizing validation workflows and driving continuous improvement initiatives.

Throughout his tenure at EdgeOne Medical, Alex has contributed to several high-impact projects, including the development of innovative testing fixtures that reduce validation time while increasing reliability. His passion for learning and innovation fuels his ability to adapt to evolving industry standards and incorporate cutting-edge technologies into his quality engineering practices. With a relentless focus on process optimization and boundary-pushing solutions, Alex Omiatek is a vital asset in ensuring the delivery of high-quality medical devices that meet both regulatory and client expectations.