Jaclyn Fickert

Biomedical Engineer

Jaclyn is a biomedical engineer with 3 years of experience in medical device development. She has spent her career working with start-up medical companies and thus has a broad range of experience in many aspects of product development. She has experience in both product design and quality, and can provide support with a variety of tasks such as development of user and product requirements, risk analysis & management, SOLIDWORKS services, and regulatory submissions.

Prior to Matrix, Jaclyn led the engineering effort for Back 2 Basics, a start-up orthopedic company focused on sterile-packed spinal implants. While at Back 2 Basics, Jaclyn was responsible for new product development in all phases; establishing user and product requirements, creating design output documents and drawings, managing V&V plans, and supplier management. She also supported Quality efforts with establishment of new procedures and increased CAPA and supplier management. In her time with the company, the small team obtained 510(k) clearances for two products, one being the first carbon composite spinal rod cleared as an adjunct in the treatment of spinal indications, and successfully sold the company assets to an acquiring party.

Since joining Matrix, Jaclyn has continued to develop a diverse skillset, supporting activities including Small Business Innovation Research grant applications, development of 21 CFR-compliant clinical study quality management systems, and IDE applications.

Jaclyn earned a Bachelor of Science degree in Biomedical Engineering with honors from the University of Akron.

jfickert@matrixmedicaldevices.com