Maciej Jakucki

Experience 

Since starting his career in materials and product testing in 2008, Maciej has partnered with hundreds of orthopedic and cardiovascular device manufacturers to solve complex problems and save lives. 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 focuses on building strong, trusting relationships with customers. He brings a meticulous work ethic to product development and testing in the medical device industry, including managing the Medical Device testing department at Element Cincinnati. In his current role as Division Director in Life Sciences overseeing laboratories across multiple states, Maciej draws on his deep technical expertise and passion for guiding teams to bring value to Element's medical device and pharmaceutical customers.

Career Highlights 

Over his career, Maciej has:  

• Performed and managed medical testing projects ranging from small feasibility studies to multiple programs encompassing all of the FDA and CE requirements 

• Routinely developed test protocols, worst case justifications, and methodologies for new and existing product support 

• Performed submission testing both domestically and internationally for hundreds of active products across the spine, joint arthroplasty, maxillofacial, and trauma industries 

• Substantially expanded Element's Life Sciences division over the past decade