As Chief Operating Officer of nView medical, I am responsible for the full product development life cycle of nView's system from concept and research to development, design controls, regulatory clearances, and market introduction. I am responsible for clinical studies and cadaver labs, and work directly with surgeons to interview and gather feedback to define user needs. Additionally I have experience in radiation and electrical safety and will be driving nView's regulatory clearance and US and international certifications.

As the Lifecycle Engineering Manager, I acted as both the technical and functional manager for the a surgical navigation product. I rebuilt the product line after it was shut down by an FDA Consent Decree including remediation of product and design history file. I met with FDA to aid in the development of FDA guidance on cleaning and sterilization of reusable instruments, and also worked closely with customers to understand and address needs.Additionally, I managed the Installed Base products, including a disposables and accessories business with revenue of $6M. I worked to develop a new distribution infrastructure for the product that was unique within the division. This was a new team, and was built from the ground up. I efficiently hired and maintained a diverse team including the completion of evaluations and merit increases. This included hiring and managing full-time employees and contractors with contracting agreements. Skills include managing and mentoring multi-disciplined teams including creation of opportunities, and creating staged development plans; working successfully with large cross-functional team both within and external to the organization.

As the Lead System designer, I was the technical lead on stand-alone surgical navigation platform. Responsibilities included worked with Marketing and Clinical to define user needs, developing requirements flow down, defining architecture/system design and risk analysis. I was responsible for system level integration, verification and validation including plan, protocols, execution, and summary. I managed >3000 defects through the definition, investigation, risk assessment, root cause, corrective and preventative actions, and closure to ensure customer satisfaction. I fostered cross-functional relationships between engineering, quality, regulatory, manufacturing, and service teams by encouraging knowledge sharing, and facilitated discussions. I participated or led FDA, VDE, 3rd party, and internal audits. All resulted in zero 483s, and only minor findings.Additionally, I was the Project Lead for systems engineering team, responsible for the planning and scheduling of tasks for a 14-member team. I developed talent within the team through coaching and mentoring to maintain zero attrition.I was also the Site Radiation Safety Officer responsible for maintaining compliance to all state regulations, leading three Massachusetts state audits, all resulted in zero findings.

As Lead Electrical Engineer, I was responsible for integrating a surgical navigation system seamlessly into a flat panel detector fluoroscope. I developed 2-year plan and tracked progress weekly for EE team consisting of 4 members; defined EE budget for complex electrical system from component design through production; and coordinated system level activities between electrical, mechanical, software, and systems teams. I created a novel registration algorithm to correlate fluoroscopic image and tracker data. Additionally I drove a complete navigation tracker re-design decreasing complexity by 75%, increasing reliability, obtaining RoHS compliance, supporting IB obsolescence, at a cost savings of 50%.As a Systems Engineer, I was responsible for increasing the navigation accuracy of a surgical navigation system including integration into a fluoroscope. I created a system level transfer function and accuracy budget for a complex imaging and electromagnetic tracking system. I developed and executed a plan to deploy a new product to manufacturing. This roll-out encompassed changes to the entire manufacturing process. I also supported all verification and validation activities of this product.

I worked on a team designing the Sensor Chip, an infrared gas sensor to detect CO2 and combustible gases. My responsibilities were to design software algorithms to correct for noise and drift on signals, programming common laboratory data acquisition hardware using LabVIEW, and completing a sensor to measure CO, CO2 and RH levels in fuel cells for a major automotive manufacturer. Additionally I designed LabVIEW program to automatically calibrate sensors, and adjust for drift over time and coded an algorithm to compute concentration and attenuation of each gas.