Integrated across all levels of the research team, from establishing and managing strategic directions with the Principal Investigators to helping students and technicians troubleshoot experiments and equipment.• Provide research leadership, expertise, and mentorship across a diverse research team and wide variety of projects. My primary focus is on establishing feasibility and potential paths for translation of cryopreservation and rewarming technologies for regenerative medicine applications, but I also support work on focal cancer therapies and organismal cryopreservation.• Co-invented technology which can enable long-term cryopreservation and banking of organs and tissues (during my graduate work in 2013). I am now helping lead research focused on demonstrating critical feasibility milestones for this complex approach, with the potential to revolutionize how donor organs and tissues are utilized for transplant and research.• Contributed to invention and development on several technology approaches which enable ultrarapid cooling and rewarming of submillimeter cryopreserved systems in a scalable manner. This has application across a broad range of regenerative medicine and research products and we are evaluating several avenues for translation including pancreatic islet transplant which can potentially enable a cure for diabetes.• Bring an industry mindset to strategic planning. Work with Principal Investigators to continually review the labs’ research focus and help set appropriate/impactful priorities. Have been helping to implement more structured research plans and updates to maintain focus on priorities. Lead several weekly meetings focused on setting and maintaining research strategy.

• Meet individually, weekly with students and postdocs to discuss research progress and plans, helping them make progress on key objectives while still maintaining their academic/scientific development.• Lead the labs’ management of Intellectual Property portfolio. Working with the University Office of Technology Commercialization and patent lawyers to litigate 12 on-going patent applications. Attempting to maintain the scope of the applications inline with potential paths for commercialization and identify areas for new IP development.• Establish and maintain relationships with industry partners. Management of 4 NIH SBIR projects.• Have supported strategy development, outlining, writing, and management of 7 NIH R01 and 5 SBIR proposals.• Have been included as co-author on 5 peer-reviewed publications (with 3 more in submission).• Manage an annual research budget of ~$1M (direct cost), including personnel allocations and forecasting needs for proposals and personnel to support research direction. Lead the lab’s recruiting efforts, including identifying and prioritizing the critical roles needed to support research directions.• Managed planning and construction on a new 1300 sqft lab space, including installation and check-out on a ~$500k, world-class system which will allow rewarming of clinical scale cryopreserved organs.• Support a positive and “team science” based culture through attitude, management, and proactive conflict resolution.

Member of a dynamic research team reporting directly to VP of Research and Technology. Core roles included early-phase technology development and basic science support of critical field efforts.• Technical lead on feasibility assessment and development for next generation RF ablation device. Worked with team to understand the key factors contributing to success of the current ablation device portfolio and leveraged these into a new concept providing significantly improved ablation performance and meeting key requirements of a new user base.Continually applied engineering first-principles and COMSOL modeling to identify the priority areas of focus (i.e. “biggest knobs”) in assessing and refining the design. The bench and lab efforts focused equally on understanding the safety profile of the design approach, testing to failure and beginning to establish safety margins. Led the technology development into Phase 1, including recommendations on device configuration, system requirements, and preliminary algorithm.• Individually conducted an investigation into a serious field complaint issue. Developed a complicated bench test to recreate and understand the design factors and use conditions that could contribute to potential adverse events. Worked with Quality to develop a fault tree analysis to better understand the system and prioritize areas of focus. The effort did not have a defined team, so I had to work collaboratively and creatively to get the work done. Provided frequent results, updates, and recommendations to management over an 8-month focused effort.

• Technical lead on feasibility assessment and development for next generation cryoablation technology. Received hand-off of preliminary evaluation from outside research consultants. Prioritized highest areas of risk for meeting key performance objectives and methodically burned them down, using combination of analytical and numerical analyses, hands-on refinement of prototype systems, and development of innovative proof-of-concept experiments. The prototype system met performance objectives on the benchtop and showed promising results in a pilot animal lab.• Technical lead on development of COMSOL numerical model for simulating bipolar RF clamp ablation device. A detailed literature review provided the framework for describing the ablation physics and parameter space for key tissue properties. The multiphysics model successfully captured the complex relationships between the power delivery algorithm, temperature-dependent tissue properties, and water loss in the tissue. The model was compared with a detailed set of benchtop tissue validation experiments, showing a high level of agreement. This modeling provided an invaluable tool for understanding the physics behind device function and for investigating future design concepts. The base model was quickly leveraged across several development efforts.• Met an aggressive timeline to refine a test model and design a series of benchtop experiments to inform a critical field usage question. The test model simulated clinical use conditions for an epicardial RF ablation device, including the impact of atrial blood flow and incorporated bovine ventricular tissue, allowing for staining and detailed assessment of lesion formation. The testing provided a well-controlled (relatively quick) comparison that would have a required a large animal study. The results clearly differentiated relative performance of ablation parameter sets being used in the field.

** Supported technology and manufacturing transfer of phased RF ablation catheters to new site; currently supporting development of next generation cryoablation catheters. • Detailed knowledge of design, operation, and testing of both phased RF and cryoablation technology platforms.• Applying established expertise in experimental design to develop well controlled test methods that accurately measure the intended device performance and clinical use conditions. Responsibilities include test method validation to ensure quality compliance.• Growing experience with clinical procedures and how devices are used in the operating room. This includes development of stacked-stress testing to mimic cumulative manipulation and stresses that will be seen by devices during their expected range of physician use and system interactions.• Statistical analysis in Minitab, including (but not limited to) distribution analysis, tolerance intervals, ANOVA, and MSA. • Exposure to sub-optimal product requirements has led to greater understanding and appreciation for the importance of effective product requirement definition and adequate requirements flow.• Application of risk management principles, including Design FMECA, Process FMECA, Use/Procedure FMECA, risk mitigation, and practical risk benefit analysis.• Planning and execution of Design Characterization, Verification, and Validation Testing, in accordance with design controls and industry standards.• Familiarity with relevant industry standards, including – ISO 10993-1, ISO 10555-1, ISO 11137-1, and ISO 14971.

Applied practical engineering principles to improve clinical application of a variety of thermal therapies. Concurrently managed multiple research projects, with collaborations across several departments and while mentoring and supervising a number of undergraduate and graduate level students. Key developments as a medical R&D engineer included:*** Hands-on Experimentation, Testing, and Modeling: ***o Regularly developed, fabricated, and validated new experimental setups and methods for testing in a variety of physical and biological systems. Ensured protocols were well-documented for future use and translation.o Benchmarked experimental results against analytical and numerical/FEM modeling in MATLAB, Mathematica, and/or COMSOL Multiphysics, to provide theoretical grounding and capabilities to extrapolate on the results.o Confirmed the impact of these findings in cellular (in vitro), tissue (ex vivo), and/or animal (in vivo) models.*** Innovation: ***o Developed and patented a new method for thawing cryopreserved biomaterials through radiofrequency heating of magnetic nanoparticles. Technology resulted in a $350,000 NSF grant for the lab and is under review for additional funding and commercial partnering through the SBIR program. o Led a collaborative research effort across four labs, to develop a new MRI-based method to quantify in vivo iron oxide nanoparticle concentration and heating potential for clinical planning in cancer hyperthermia applications. This has produced two new technology disclosures that are under review for patenting by the university.

*** Medical Device Design and Development: ***o Project lead on six student, multidisciplinary engineering/business team, tasked with design and development of an endoscopic probe for ablative treatment of Barrett’s Esophagus.o Developed a detailed understanding of the medical condition and current treatments through patient observations, physician interviews, competitor analysis, and background research.o Conducted intensive design process, including: voice-of-customer, product specification, concept generation and selection, modeling, DFM, prototyping, physician evaluations, and preclinical testing plan.o Device prototyping included thermoforming of nitinol for superelastic conformation to the esophageal geometry.o Project deliverables included a draft patent application and functional prototype.*** Adaptability: ***o Highly motivated by new technical challenges and this provides the ability to quickly develop new areas of expertise. Graduate research encompassed a wide range of technical areas, including – bioheat transfer, biomaterials, biomedical nanotechnology, RF heating, cryoablation, cryopreservation, and clinical imaging.o Submitted a first-author textbook chapter on magnetic nanoparticle based hyperthermia less than a year after beginning work on the subject. Co-author, Dr. Andreas Jordan, is the lead researcher in the field and accepted the manuscript with only minor comments.o Served as technical liaison for a two-year project sponsored by the law school (10 hrs/wk). Interacted with FDA regulators to understand existing approval pathways and their limitations for regulating nanomedicine products.

Significant experience as technical project lead in manufacturing, pilot, and lab facilities. Completed over 35 projects, coordinating highly cross-functional teams. Projects ranged in size from $10K to over $1 million.• Exposure to a wide range of manufacturing technologies, including- coating, extrusion, sealing, microstructured materials, web-handling, machine-control, precision measurement, injection molding, and laser-processing.• Regularly applied voice-of-customer to translate “project requests” into well-defined and measurable equipment, process, and project specifications. Worked hard to reach consensus decisions and buy-in from all stakeholders.• Ensured compliance with ISO, OSHA, and internal safety standards in designing equipment and managing projects.• Interacted directly with both internal design groups and external vendors/fabricators.• Applied Six Sigma tools (including DOE, Pugh and Concept Selection Matrices, C&E, FMEA, RACI, and Stakeholder Analysis) to develop design specifications, evaluate design alternatives, and reach consensus decisions.• Worked with process scientists to design and install upgrades on pilot and manufacturing co-extrusion lines to support a wider range of products.• Specified and designed a new automated laser system for etching and cutting metal tooling for extruded casting.• Became expert on business-critical retroreflective metrology instrumentation (Quality Control). Helped lead technology development and migration planning for the equipment across several divisions.• Prepared a $2.5 million project plan for new production and converting operations in Singapore. Evaluated vendors in twelve different countries to identify optimal equipment strategies based on cost, performance, and delivery schedule. Obtained near perfect score on project pre-planning report card (rarely achieved).

• Redesigned snowplow mounting to improve safety and simplify blade change-out procedure. Replaced manual bolting system with a series of hydraulically-actuated pins. Design eliminated the need for excessive maneuvering and lifting beneath the truck and reduced change-out time by factor of four.• Responsible for all aspects of project from conception to implementing prototype trials.

• Designed and conducted two-level, factorial experiments to investigate effects of part alignment on yield of automated, microscopic soldering process. Subsequent analysis produced a four-factor transfer function that was used to optimize the process yield.• Conducted several similar investigations to validate process design changes and isolate sources of product failure.

• Analyzed performance data on international project change-orders to identify indicators and root causes. Defined dimensions of analysis and provided data-drive recommendations for improvement to the project management process.• Developed hierarchal structure and database for categorizing global suppliers and equipment, to facilitate analysis of supplier-related processes.

• Worked with design engineers to understand the drawing support process and create organizational system to increase efficiency of support response.