Brian Binkowski
About Brian Binkowski
Brian Binkowski is the Principal Quality Engineer Digital Health at Boston Scientific, with extensive experience in quality assurance and compliance in the medical device industry.
Title and Role at Boston Scientific
Brian Binkowski is currently employed at Boston Scientific as a Principal Quality Engineer in Digital Health. His tenure at the company, starting in 2020, involves responsibilities related to ensuring compliance with regulatory standards and maintaining high-quality standards in digital health technologies.
Professional Experience at Medtronic
Brian Binkowski has accumulated substantial experience in various roles at Medtronic. From 2019 to 2020, he served as the Quality System Manager in Boulder, CO. Prior to this role, he worked in Quality System Compliance from 2016 to 2019. His responsibilities spanned ensuring adherence to quality systems, managing compliance, and supporting manufacturing processes under various regulatory frameworks.
Previous Roles in Quality Assurance and Engineering
Brian Binkowski has held multiple positions in Quality Assurance and Engineering across diverse companies. He worked at Sandhill Scientific, a Medovations Company, as a Quality Assurance professional from 2015 to 2016 in the Greater Denver Area. In the same region, he was employed by SEAKR Engineering as a Quality Assurance Engineer from 2014 to 2015. Additionally, he briefly worked at Medical Modeling in Golden, CO, as a Quality Engineer in 2013.
Education and Certifications
Brian Binkowski holds a Bachelor of Science in General Engineering, Biomedical, and Industrial Manufacturing from California Polytechnic State University-San Luis Obispo, where he studied from 2006 to 2011. He is also certified as a Lead Auditor for ISO 13485:2016 through BSI TPECS, signifying his expertise in medical device quality management standards.
Expertise in Quality and Regulatory Compliance
Brian Binkowski possesses extensive expertise in international standards compliance, including ISO 13485:2016, ISO 9001/AS9100, and additional global regulatory requirements such as MDD 93/42/EEC, MDR EU 2017/745, and US CFR Part 820. He is proficient in managing both high-volume medical device manufacturing and low-volume custom medical devices for Class II and Class IIb products. His knowledge extends to ISO 60601-1 and 60601-2 standards, Usability Testing, Software Validation, UDI Labeling Compliance, and Risk Management under ISO 14971. He has also worked on histology compliance for 21 CFR Part 58 (GLP).