Gisselle Cunningham Email and Phone Number

www.nephrodite.com

- Supported new product development of the first tankless inhaled nitric oxide gas drug delivery system (GENOSYL DS) indicated for the treatment of cardiopulmonary hypertension and related conditions.- Led all system engineering related tasks and deliverables, including the creation and management of all 500+ system and software level requirements, to support system field releases and regulatory submissions.- Led and established risk management strategies per ISO 14971, identifying and mitigating 100+ potential hazards and failure modes to ensure the safety and efficacy of the GENOYSL DS system.- Oversaw the creation and maintenance of comprehensive design-controlled documentation per 21CFR820, including design requirements, detailed design specifications, test protocols, and technical reports, to support regulatory submissions and audits.- Established and fostered relationships between key stakeholders, including commercial and clinical teams, quality assurance, regulatory affairs, and leadership, to facilitate the successful completion and regulatory approval of all new product development.- Played a key role in driving process improvements and implementing systems engineering best practices to enhance efficiency and streamline workflows in order to lay the foundation of the Systems Engineering department.- Provided technical leadership and mentorship to a multidisciplinary team of engineers, fostering a culture of continuous improvement, collaboration, and innovation.

- Supported new product development of the next generation of endoscopy scope and controller devices facilitating system engineering related tasks, deliverables, and training.- Co-developed preliminary product definition documentation including technology feasibility assessments, design and development plan, user needs, system definition and architecture documents, and system requirements.- Divisional project lead managing the integration of a new requirement management software tool (Cognition Cockpit) focusing on increasing productivity efficiencies to improve time to market and project costs.

- Co-developed and managed system and sub-system requirements, feasibility testing and analysis, preliminary hazard analysis and risk assessment, use cases, user stories, GUI wireframe and software application development, requirement traceability, and verification strategy planning for BD’s next-generation of Class 2 infusion pumps to provide life-saving treatment to NICU/PICU/ICU patients.- Collaborated and led cross-functional requirement elicitations, technical discussions and formal design reviews across multi-disciplinary teams including Engineering (Software, Electrical, Mechanical, Firmware, Human Factors and Operations/Manufacturing), Marketing, Medical Affairs, Human Factors, Quality, Regulatory Affairs, and external co-development team.- Applied product line engineering principles to create a multi-level, interdependent DHF development plan to develop a modular system-of-systems device that aligned with regulatory submission requirements and the business’s commercial release strategy.- Initiated migration of requirement management tool to Azure Dev Ops Modern Requirements from DOORS.

- Co-developed and managed system definition, architecture, system and subsystem requirements, risk management and system traceability of next-generation Class 2 implantable integrated continuous glucose monitoring (iCGM) device for the treatment of diabetes.- Collaborated and led cross-functional technical discussions and design reviews across multi-disciplinary teams: Engineering (Software, Electrical, Mechanical, Firmware and Operations), Marketing, Medical Affairs, Quality, Regulatory Affairs, and User Experience.- Managed sustaining products’ system level requirements including software requirements, software hazard analysis and risk management, as well as conducted sustaining products’ CAPA and MDR remediations.- Co-led clinical trial system requirement development and label verification for IRB submission.

Neural Analytics is reshaping brain health management through the development of diagnostic, monitoring, screening and therapeutics technologies for the improvement of patient outcomes.- Contributed to the FDA clearance and CE marking documentation, submission, and approval of the first to market transcranial ultrasound robotic system - the Lucid Robotic System.- Supported the development of the Lucid Robotic System that non-invasively measures and analyzes metrics of the neurovascular health of the brain indicating a stroke, traumatic brain injury (TBI) or a patent foramen ovale (PFO). - Engineering liaison between product development teams (Software, Embedded, Mechanical, Electrical and Robotics), Marketing and key opinion leaders (KOLs). - Elicited and managed all user needs, system and subsystem requirements including software requirements for the Window based ultrasound system. - Conducted feasibility, performance and reliability testing to determine requirement acceptance criteria.- Additionally conducted risk assessment, design failure mode analysis, task analysis, formative and summative usability studies.

- Supported the development of the next generation of microelectronic implantable technologies, most specifically the Spinal Cord Stimulators (SCS) and Deep Brain Stimulation (DBS) systems, for the management of chronic neuropathic pain and neurological diseases.- Supported the integration and unit testing of all hardware, firmware, and software systems of SCS/DBS system components in order to comply to all federal and international regulatory standards for Class 3 medical devices.- Developed hardware, firmware and software instrumentation and integration tools, along with system verification strategies for the production and successful operation of all Boston Scientific’s SCS/DBS systems.Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com.Projects: Implantable Deep Brain and Spinal Cord Stimulating SystemsRelated Link: https://www.controlyourpain.com/spinal-cord-stimulation/?s=difference

- Under the guidance of Dr. Jonathan Viventi, supported the research and development of implantable, flexible electronics for medical applications targeting neurological debilitations and disorders.- Led the research and development of long-term reliability studies analyzing the electrical degradation properties of implantable brain devices – experiment funded by DARPA.- Supported the development of a non-invasive, cost-effective breast cancer screening modality using Electrical Impedance Tomography (EIT) and high-density, flexible electrode arrays.- As an NSF Graduate Teaching Fellow, curated and taught mechatronics/robotics to GK-12 school programs within the Brooklyn inner city school district.www.tneuro.com

GK-12 Graduate Teaching Fellow in fellowship with the AMPS/CBSI Fellowship Program - the AMPS/CBSI Fellowship is a collaborative partnership among NYU Polytechnic School of Engineering faculty, NSF Graduate Teaching Fellows in K-12 Education (GK-12 Fellows), GK-12 teachers, GK-12 students and corporate sponsors aiming to broaden the educational experience within Central Brooklyn GK-12 schools by enhancing technological proficiency of teachers and affording educational opportunities to GK-12 students. Weekly, GK-12 Fellows are engaged in in-classroom interactions with GK-12 teachers and students, within Central Brooklyn schools, in order to challenge students to develop, enhance and apply their science, technology, engineering and math (STEM) skills learned within the classroom towards out-of-the classroom engineering experience in designing, building and operating robotics devices that will ultimately participate in the annual US FIRST Robotics competitions.

- Team lead in directing developmental bring-up for IBM’s POWER 750 system’s hardware and technology solutions brought to market in 2013 delivering state-of-the-art computing performance and workload optimization to the global IT market. - Helped deploy IBM’s high-computing Power7+ healthcare IT solutions established to improve the quality of patient point-of-care and the efficacy of electronic healthcare record transactions. - Supported the development of IBM’s Power7+ high-computing processing unit incorporated within IBM-Watson cognitive computing system designed to tackle complex healthcare analytics improving upon daily healthcare decisions.- Developmental testing techniques include electrical circuit and schematic analysis, physical/functional logical and timing analysis, large system stress, shell scripting, digital hardware programming, chip integration, performance modeling, hardware characterization, power optimization and management, etc.- Components developed and tested include integrated digital circuits, semiconductor chips, embedded micro-controllers, memory and logical units, storage devices, IO systems and devices, communication buses and interfaces, power supply, operating systems, firmware, etc.

- Assisted supervisor with relevant projects relating to OMEGA® DPi32 iSeries thermocouple meter, including programming and simulating with LabVIEW.

The Jet Propulsion Laboratory is the lead U.S. center for robotic exploration of the solar system, and conducts major programs in space-based Earth sciences and astronomy. JPL spacecraft have visited all of the planets from Mercury to Neptune.As a student intern:- Designed, fabricated and C++ programmed the entire circuitry of a universal programmable RS-232 controller that received/transmitted serial commands to control multiple lab devices and equipment.- Assisted in programming and assembling a time-elapsing video capturing device that assists scientists in analyzing spacecraft construction.

The Jet Propulsion Laboratory is the lead U.S. center for robotic exploration of the solar system, and conducts major programs in space-based Earth sciences and astronomy. JPL spacecraft have visited all of the planets from Mercury to Neptune.As a student intern:- Used C++ and KML programming languages to interface JPL’s Mars Yard’s coordinate system with Google Earth, which shows in-depth imagery of robotic rovers’ trajectory paths for testing.