I have 13 plus years of experience in International Compliance for Electrical Safety and Sanitation of Commerical Appliances, Medical Devices and Laboratory Equipment.
My focus over the last 10 years has been with Medical Devices (60601) and Laboratory Equipment (61010) including Risk Management (ISO 14971), Usability (62366), Software (62304), and Quality Management Systems (ISO 13485) used for FDA, and EU MDD/MDR, and GMP. I also have 10 plus years of experience managing the Quality System of an ISO 17025, OSHA NRTL, and CB Scheme accredited safety testing laboratory and as Lead Auditor of other such laboratories. I am client-focused and have an exceptional knowledge of conformity assessment, quality assurance, and project management.
I have a passion for solving problems and for the Medical Industry. At one point I wanted to be a veterinarian and then a doctor because I am very interested in the biology of life. I have a passion to be involved with life changing work that improves and saves human lives such as life saving/sustaining medical devices.
I love spending time with my family and friends. My husband and our 2 little boys love the outdoors and adventure - kayaking, hiking, camping, fishing, sports, etc. I also practice yoga and love to read. My play time is usually booked solid with new activities, adventures, or restaurants to try.
What is your first memory of design thinking?
As part of my Senior Design Project in University, I wanted to know if a building material just as strong as concrete could be used to help create rural housing with more stability in rural/tribal South Africa. Historically, many cultures use a combination of mud, rock, and animal dung for building their homes and many times the structural integrity of these homes is lacking in strength and far from the standards we take for granted as part of a developed country which leads to unsafe homes which collapse more easily. I wanted to prove that in adding a smaller sustainable amount of our typical US concrete mixture to their normal recipe that the building materials could be strengthened to be near or equivalent to the 100% concrete building materials we have available to us here in the US.
First, I learned all I could about the problem, I learned about the culture (and even visited rural/tribal communities in South Africa), the construction methods that were used, the lifestyles of the residents, the surrounding flora and fauna, weather patterns, and even politics. Second, I thought through all possible solutions in using alternate materials but found that it would be cheapest and most accepted to transport a small amount of our US concrete mixture to the area or make nearby in a larger city to be added into their traditional mixture.
So I tested many different ratios of rock, mud, clay, and standard concrete mixture to determine which combination would maintain the required strength with the smallest amount of added concrete mixture. In designing this new material, I partnered with a design team and a local university in South Africa. I had to understand the final structure, the materials that would be used, and the culture of the residents and I learned this by visiting South Africa and visiting the same communities I was trying to help. We were able to come up with a ratio that would be most cost effective for all and would require the least amount of change for the community and culture.