SILICONE. MEDICAL. EXTRUSION.
Shaping the Future of Silicone
SiMEDEx was launched in 2017 to do one thing and to do this exceptionally well. As our name suggests, SiMEDEx focuses exclusively on Silicone, Medical, Extrusion.
SiMEDEx’ founders have been awarded 10 US Patents for advancements in silicone extrusion equipment, processes, and raw materials. This expertise has earned us the trust of 100+ customers spanning 21 countries. SiMEDEx’ recent technical achievements include micro-tubing with wall dimensions as thin as 0.002”, various types of reinforced tubes, layered geometries containing antimicrobial additives, and multi-lumen twisted tubes meeting tolerances of less than 0.001”.
We are an ISO-13485:2016 certified company with a robust quality system supporting the medical device community in both implantable and non-implantable applications. We operate 6 extrusion lines each scalable to meet our customers’ expectations. Providing exceptional customer service is as important as providing the highest quality silicone extrusions.
We strive to answer all inquiries within 24 hours, quotes are generally delivered within 48 hours, and many jobs are completed within 2-8 weeks depending on materials availability and cooling lead times.
Our Services
Wherever you are!
SiMEDEx has representation around the world. Our experienced, established, and knowledgeable reps will help you find exactly what your company needs with our capabilities. Our reps cover various territories in North America, South America, and Europe. Request a quote with us and we will connect you with a rep that best suits your needs and region.
Don't see your region represented on the map? Reach out to our SiMEDEx team for more information.
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Meet the Team
The SiMEDEx leadership team was purposely selected to pull together expertise across various disciplines.
President
Paul E. Mazelin
Paul serves as the President of SiMEDEx. Paul literally grew up in the silicone business. His father was a co-founder of Specialty Silicone Fabricators and Paul was inquisitive about the silicone contract manufacturing business from an early age. Prior to launching SiMEDEx, Paul worked for 22 years at SSF where he held various key positions including R&D Manager, Strategic Accounts Manager, and later Global Sales and Marketing Manager. His technical expertise, coupled with his understanding of manufacturing cost-drivers, allows him to collaborate with engineers on initiatives that improve manufacturability, drive down costs, and reduce lead times for both implantable and non-implantable medical device applications.
T: 805.610.6444
Chief Technology Officer
Charles Schryver
Charles’ silicone career has spanned over 34 years. Mr. Schryver served as Specialty Silicone Fabricators’ VP of Engineering and R&D for 23 years. In this role, Mr. Schryver developed equipment and processes that resulted in GeoTrans®, a technological breakthrough that allowed tubing geometries to be modified during the extrusion process. Mr. Schryver was awarded 5 US patents for his work related to transitional silicone extrusion equipment and processes. Charles was later recruited by Helix Medical (Freudenberg Medical) where he spent 5 years overseeing their silicone extrusion operation. Charles later launched a very successful consulting enterprise and has traveled widely advising silicone extrusion clients in the Americas, Europe, and Asia. Charles attributes his successful career to his approach to engineering which he describes simply as “hands-on”.
Director of Manufacturing, Operations
Frank East
Frank started working in the medical silicone business in 1998. His time at Specialty Silicone Fabricators was spent as a Product Manager over Extrusion and Molding, a Business Unit Manager over the Dipping/Sheeting department, and as a Marketing Manager over all the lines of business. He then went on to work as a Business Development Manager for Qure Medical. In that position, he was responsible for sales of silicone and rubber/plastics for the western region where he analyzed and monitored potential growth opportunities and partnerships. Frank also started a sales and consulting firm called East Polymer Sales Engineering, LLC. He sourced new customers/leads for clients, analyzed market opportunities/solutions and he developed and executed business and marketing plans.
T: 805.610.6344
Director of Business Development
Joe Pignotti
Joe has been involved in sales and marketing to the medical OEM extrusion/device market for over 30 yrs. Started with Fluortek Inc. a PTFE, fluoropolymer, and thermoplastic extruder (now Nordson) and was VP of sales and Marketing. He was also sales manager at Sanbor Medical, a Medical device producer of finished electro and mechanical devices. Currently the Director of business development with Simedex.
T: 484.560.4247
Director of Quality
Kim Jolliffe-Meeks
Kim Jolliffe-Meeks brings to SiMEDEx over 25 years of experience in the Quality Departments of major medical device and pharmaceutical
companies including Abbott Laboratories, Baxter, and Novartis. She has an expert's understanding of Quality System requirements for
silicone contract manufacturing having served as Vice President of Regulatory and Quality Assurance at SSP-SiMatrix and later as Quality
Manager at Specialty Silicone Fabricators. Ms. Jolliffe-Meeks has a successful track record for managing complex performance issues while
implementing initiatives that ensure continuous improvement within ISO 13485:2016 and 21 CFR Part 820 systems.
At SiMEDEx, we’re always looking to add exceptional talent to our team. If you have experience in silicone extrusion, let’s connect to explore current opportunities.
We focus exclusively on Silicone, Medical, Extrusion. SiMEDEx’ founders have been awarded 10 US Patents for advancements in silicone extrusion equipment, processes, and raw materials. This expertise has earned us the trust of 100+ customers spanning 17 countries.