Steven Schaefers

Background

About Steven Schaefers

Providing support in the areas of Product Development, Technology Transfer, Manufacturing Readiness, Scale, and Continuous Improvement. Ayzeon provides team building and operational alignment to growing companies.Our mission is straightforward: to facilitate the pre-production for R&D, to setup and organize tech transfer, to ensure manufacturing readiness, to prepare an operations team, to produce pre-product/production and to scale efficiently.Ayzeon understands firsthand that transition and change are challenging. That these paths are filled with roadblocks, resource restraints, and regulations. To support this arena Ayzeon brings a deep understanding of ISO-13485, CE, and FDA regulated environments. He knows how to work through barriers to achieve defined goals. Ayzeon provides a Hands-On leadership style keeping geared to team engagement. They work with suppliers & contractors aligned, and the projects visible, on plan, and in control.Throughout the founders career, he's successfully overseen most aspects of Manufacturing Operations, i.e, Supply Chain, Product Development, Manufacturing Engineering, Facilities Management, Mfg. & Production, Technology Transfer, V&V, Stability, and Scaling along with maintaining an excellent audit approval record. Ayzeon's goals are simple: to help organizations develop solutions for their production. To make sure newly developed technologies are designed for manufacturing, transferred with supporting methods, including documentation and too ensure the working environments are ready to meet the Demands of Sales Ayzeon is on LinkedIn to strengthen business relationships, make new connections and learn. They can be reached directly at: steven@ayzeon.com Ayzeon is always interested in providing insight on manufacturing operations and/or compliance in the medical device space.