Maciej has performed and managed medical testing projects ranging from small feasibility studies to multiple programs encompassing all of the FDA and CE requirements.
Maciej obtained his Biomedical Engineering degree from Drexel University in Philadelphia, PA and has worked in product development and testing in the medical device industry for most of his career, including his current role managing the Medical Device testing department at Element Cincinnati.
Maciej has nine years of experience working in the medical device and pharmaceutical industries. His expertise is in medical device testing and analysis as well as support of FDA 510(k) and CE submissions. He is an active ASTM member and routinely contributes to driving the industry forward. Maciej has performed and managed medical testing projects ranging from small feasibility studies to multiple programs encompassing all of the FDA and CE requirements. He routinely develops test protocols, worst case justifications, and methodologies for new and existing product support. He has performed submission testing both domestically and internationally for hundreds of active products across the spine, joint arthroplasty, maxillofacial, and trauma industries.