James Waring

I manage the portfolio of business opportunities being investigated by our upstream marketing and engineering teams. I work with key business leaders across sales, marketing, and engineering to drive consensus regarding strategic investment of internal and external resources. I also lead user-centered design activities throughout these investigations.

I led a cross-functional integration team of 100+ individuals across 50+ countries to complete the integration of Berchtold GmbH & Co. KG into Stryker's international sales organizations. I oversaw integration activities in sales, marketing, manufacturing, supply chain, regulatory, quality, legal, compliance, and finance.

I was responsible for managing project timeline, budget, and resourcing for multiple product lines (both domestic and international) worth $40 million in annual revenue. I contributed to the 3-5 year strategic roadmaps and led user-centered design activities. This included a user-research effort across 19 hospitals & surgery centers to identify customer needs, A/B usability testing of wireframes, and customer focus groups. In addition, I managed and mentored a team of 5 engineers (mechanical/electrical/software) responsible for developing endoscopic visualization and integration products.

I was the lead mechanical engineer for the wireless endoscopic visualization system from concept through production. I designed, prototyped, and manufactured over 40 components across 3 products that were brought to market in 2013. Through this I became well versed in designing sheet metal, machined, and injection-molded components for electrical device assemblies, particularly those involving wireless hardware. I also contributed to leading the cross-functional project team through design control requirements including identifying customer needs, writing functional specifications, assisting with verification & validation testing methods, and overseeing the manufacturing production methods.

One of 5 founders of a medical device start-up focused on bringing an umbilical cord blood collection device from concept to reality. I contributed heavily in prototype conceptualization and construction, IP and regulatory strategies, and business plan development. My primary responsibilities included the product design as well as the commercialization strategy to attract investors. During my time with the company we filed a provisional patent surrounding the method for collecting stem cells, developed an initial prototype, and won over $143,000 in prize money from business plan competitions and technology grants.

As part of the Center for Bioengineering and Design, I immersed myself in the ins and outs of medical device product development. During my time, I spent over 350 hours with clinicians in the General Surgery, Emergency Medicine, Transplant Surgery, & Otolaryngology departments at Johns Hopkins Hospital to identify and validate unmet clinical needs. I also had the opportunity to spend 2 weeks in the emerging markets of India and Nepal meeting with government health officials as well as hospital and health post staff to understand the challenges of designing medical devices for these markets. This culminated with my contribution to a USAID sponsored project to develop a novel point-of-care antenatal screening kit for expectant mothers in these rural locations.

I split my time with Michelin between serving as a tire design engineer responsible for translating tire architecture into manufacturable product and serving as a quality assurance engineer at a tire production facility with a daily output of 24,000 tires. I implemented tire design changes that equated to over $350,000 in total savings over 12 months in addition to working on the next generation of replacement passenger car tires. Through this experience I gained knowledge of different manufacturing environments and how to incorporate design for manufacturing and assembly principles into good design.

At the McDevitt Research Laboratory, I contributed to research investigating the influence of stem cells on their microenvironment during early stage development. Working on my own project, I was able to develop sterile lab techniques including cell culture, BCA protein quantification, qPCR gene analysis, ELISA, gel electrophoresis, and histological analysis. In addition I developed a novel cell migration analysis method using MATLAB software and helped author a peer reviewed journal article.

I worked as engineering intern in various departments with GE's Energy Division gaining insight and experience in design, manufacturing, customer service and support, and Six Sigma and Lean principles. My work included design of the compressor section of a new gas turbine, field application engineering, and plant support for an energy plant in Qatar.

I aided with the design of a new headgear to support functional Near-Infrared Spectroscopy (fNIRS) instrumentation for experimentation being conducted on pilot’s stress during flight simulation.