Fallbrook Engineering Associate Spotlight: Senior Research Associate
Posted on Tue, Jan 03, 2012
Dr. Stephen Coulter, a Senior Research Associate at Fallbrook Engineering, is a biomaterials scientist with over 25 years of experience in the design, product development, process development, package engineering, manufacture, regulatory clearance and business development for medical devices. His experience ranges from surgical implants (wound healing, biomaterials, biodegradables, orthopedics, cardiovascular surgery, urology, neurosurgery, ophthalmics and gastroenterology) to consumer products (family planning, oral care, skin care and consumer packaging). He has been involved in the development of products for the U.S. as well as international markets. Dr. Coulter is well-versed in the requirements and implementation of design control, ISO 13485 and CE marking. He has technical expertise in the arena of materials science, especially biomaterials, materials compatibility, materials processing, surface modification techniques and materials characterization, both for product development and for failure analysis.
Dr. Coulter has held a number of technical management positions with Baxter Healthcare, Carter-Wallace and Church & Dwight, as well as two start-up companies for female incontinence and chemical/biological sensors. In this role he has expertise not only in product/business development, but also technology assessment, compliance and regulatory reviews and cost-improvement programs.
Dr. Coulter earned joint PhDs in Organic Chemistry and Polymer Engineering from the University of Michigan. He has been granted 6 patents in different product fields. Most recently his work with Fallbrook Engineering includes research and selection of materials, processing methods and sterilization methods for a bioresorbable stent, as well as polymer characterization and research for an IDE submission. In February he and Richard Meyst, President and CEO of Fallbrook Engineering, will present together at MD&M West.