Bio

Director of Global Business Development at Medical Device Pros, LLC

B.S., Chemical Engineering with minor in Bioengineering

MBA, International Business

Ms. Gardill has over 25 years’ experience encompassing engineering and management from the pharmaceutical and medical device industries. She possesses deep expertise in specifying, starting up, and improving equipment at FDA-regulated companies, including equipment for producing nitinol stents, and for processing Class I lotions and gels. Through her project management roles, Ms. Gardill also has broad, concept to commercialization experience across several categories: pain management & ADHD transdermal drug products, chemical and physical sunscreens, softgels and liquid nutritionals, wound care gels, powders, and molded products.

Ms. Gardill has led multimillion-dollar global equipment launches, involving 20+ person teams in the U.S., China, Brazil and Germany. She managed a department of Green Belt- and Black Belt-certified Engineers as they supported and improved manufacturing processes for nitinol stents, stent-loading, guiding catheters, and guidewires. In that capacity, Ms. Gardill directed FMEA, Design of Experiments, Test Method Validations, IQ, OQ, PQ, Validations, etc. She trained engineers for FDA audit readiness. Ms. Gardill started her career at Abbott Laboratories, where she developed and documented cleaning procedures for Add-Vantage I.V. bags, and was the process engineer for the first equipment installation for Ensure nutritionals.

Ms. Gardill has recently received 2 U.S. Utility patents for her own inventions. She has been granted 2 U.S. trademarks. She also has 2 continuation patent applications filed with the USPTO.

In 2014, together with Dr. Dwight Back, Ms. Gardill co-founded Medical Device Pros, LLC. Medical Device Pros, LLC is an engineering consulting firm for the medical device industry. Ms. Gardill currently manages the business development for this company, and also handles its consulting projects that require her engineering expertise.