CORPORATE PROFILE: The design/development/manufacturing division of Provision Healthcare. RESPONSIBILITY PROFILE: In my latest role (2021 – Present), I report to the President with three direct reports. I am in charge of all engineering operations and product development, including innovation, architecture, design, analysis, documentation, and testing large complex systems embracing electrical, mechanical, thermodynamic, cryogenic, and sensing/controls disciplines to meet regulatory standards. As Director of Engineering (2017 – 2021), I reported to the VP of R&D with 25 employees and four direct reports. Responsible for leading a cross-functional team in charge of electrical and mechanical hardware design, systems engineering, customer interface documentation, change management, and innovation/design improvement to reduce proton therapy system component and installation costs.ACHIEVED IN THESE ROLESENGINEERING LEADERSHIP• Engineering designs suffered from completion delays, not meeting user needs, and unexpected problems, so I determined to intervene. Over three weeks, I navigated change resistance to develop a new design process that ensured minimal rework and improved accuracy. I then met with managers to refine and develop procedures, presented, and won buy-in from functional leaders. Once rolled out, the new process was declared SOP and delivered time savings by reducing errors and rework time.R&D / REGULATORY LEADERSHIP• After the PTS design and V&V were completed, the VP of R&D tasked me to develop a change-management process to capture changes consistent with our Quality Management System, thus maintaining FDA compliance. I planned the strategy to update the current incomplete processes, then partnered with the Systems Engineering BU to manage development. The new process evaluated risks, tested changes, and enabled direct field implementation of this 510K-cleared device.

ACHIEVEMENTS CONTINUEDTEAM LEADERSHIP / COACHING / MENTORING• Misunderstandings and poor team unity led to inefficiencies. Determined to restore order, I began hosting a series of Engineering presentations in which team members were able to present specific work efforts, problems they encountered, and how they arrived at solutions. I worked with the presenters to choose topics, discuss and review presentation content, and provide constructive feedback. I also encouraged discussion during presentations to help inform the entire team of the excellent work being done. These efforts aligned the team toward a shared vision, improved morale, enhanced communication, and allowed more efficient and timely design efforts. R&D promoted the efforts as fostering greater efficiencies.PROJECT MANAGEMENT• After previous teams failed, the VP of R&D called upon me to create a mechanism for calibrating and testing the PTS’s camera system to track objects with heightened accuracy and timeliness. Despite attrition, I analyzed capabilities, gathered resources/funding, rewrote the software, and developed and implemented a calibration process. Testing and verification were successful, and these efforts resulted in an SOP that could be executed in any PTS treatment room in ~4 hours, which shortened the process by 10X.

RESPONSIBILITY PROFILE: As Director Systems Engineering, I reported to the VP R&D (with 10 direct reports) and was responsible for requirements generation for the proton therapy system, verification/validation, test planning and execution, risk analysis, regulatory testing, management of intersystem interface architecture, and driving completion of Independent Safety System (ISS) and Dose Delivery System (DDS).ACHIEVED IN THIS ROLETESTING & VALIDATION• Before the Proton Therapy Systems (PTS) product could be used to treat patients, it had to pass Verification & Validation (V&V) testing. The Vice President of R&D charged me to lead efforts. I led the test writing endeavor and wrote tests for the first six months. Over the next six months, I co-managed test execution with one of my managers. We then reviewed and dispositioned test results and informed adjustments/rewrites when. PTS passed V&V, and this testing framework became SOP for future projects. I was promoted to Director of Engineering as a result.MEDICAL DEVICE DEVELOPMENT• Upon purchasing crucial IP pertaining to a PTS DDS, it became apparent the DDS would not meet business needs. The VP of R&D tasked me to complete a redesign. Over the next 18 months, I consulted SMEs, created requirements, crafted a budget and schedule, and led research and development of the new design. Once completed, prototype and finished devices were created and integrated into the PTS. These efforts enabled FDA 510K testing, and to date, the dose-delivery system remains state-of-the-art, which ranks the PTS as world-class. This was a contributing factor in my being promoted to Director of Engineering.

RESPONSIBILITY PROFILE: Reporting to the Director of Engineering with seven direct reports. Responsible for leading development for the ISS and DDS of the SC360 proton therapy system, which included requirements development, design architecture, component design, test planning, and technical management of the design engineering team.ACHIEVED IN THIS ROLEDESIGN ENGINEERING / VALIDATION / TESTING• Leadership challenged me to complete the design, installation, and testing for the PTS’s ISS and DDS within 24 months. Within 20 months of assignment, I led a team throughout multiple regions in high-level design and equipment selection for the systems. I analyzed completed designs, reviewed test procedures/results, and completed installation efforts. Functionality allowed these systems to be completed and tested with very little change at follow-on sites, controlling costs, and minimizing design change risk. The ISS and DDS designs became the ProNova standards for the PTS.RISK MANAGEMENT / MITIGATION / REGULATORY COMPLIANCE• Because of multiple new features, I was charged by leadership to craft a risk management framework to ensure PTS’s compliance with the international ISO 14971 requirements. I researched ISO standards and co-wrote a process document to meet them. In addition, I co-wrote Design Failure Mode Effects Analysis (DFMEA) and Hazard Analysis (HA) documents. The process was successfully created despite being simultaneous to the design and installation of the PTS itself. Compliance with ISO 14971 was achieved as a result, which enabled completion of the PTS 510K.

CORPORATE PROFILE: A designer, manufacturer, installer, and servicer of online bulk material analyzers and process control equipment. RESPONSIBILITY PROFILE: As President of Energy Technologies (2009 – 2014), I reported to the CEO with a $3M Revenue Goal and nine direct reports. I led the effort to expand the customer product base and improve product offerings, which included product hardware and software development, customer sales support, customer interfacing, procurement, production, scheduling, and service management. As VP of Engineering (1994 – 2007), I reported to the President/CEO with a $2M Revenue Goal and five direct reports. My duties included electrical and software product design, engineering management, designing specialized interfaces for integrating products into customer applications, and driving service/support revenue. I also developed/patented a software interface for an accurate full stream elemental analyzer.ACHIEVED IN THESE ROLESSYSTEMS INTEGRATION• For decades, the technology to analyze full coal streams in real-time had been desired but not invented. The President/CEO called upon me to combine an existing product with a Prompt Gamma Neutron Activation Analyzer for such a capability. I met with the PGNAA designer to understand their device implementation, then integrated the products over four months, resolved patent/control ownership, and conducted testing. The resulting Full-Steam Elemental Analyzer sold 5-7X the price of regular ETI products and enabled relationships with larger utility companies.

Responsible for engineering management and design for niche industry instrument company with $25M in sales and service since inception in 1994 and served key role in making company a recognized leader in on-line coal analysis; customer base expansion of 15 to 150+.

CORPORATE PROFILE: A life sciences company. RESPONSIBILITY PROFILE: With Protein Discovery, I reported to the President/CEO with four direct reports. I was responsible for electrical, mechanical, and software design for company products, selecting vendors for instrument components, component production (machining, RIM manufacturing, injection molding, PCB manufacturing, and assembly), and working with PDI management to secure venture capital funding.ACHIEVED IN THIS ROLEPRODUCT DEVELOPMENT AND STRATEGY• PDI’s MALDIPlex technology was not meeting user needs, and sales were eroding. The President called upon me to develop a new product to provide an alternate revenue stream and improve acquisition potential. Over three months, I sourced the information for a potential product, contacted the authors to gather more feedback, gained approval, led the design, and ensured that multiple experiments could be done quickly while employing the new design. These efforts delivered the GelFREE instrument to market, and the company was able to generate additional cash flow by selling the IP.