Meet Melissa

Position Summary:  CMD MedTech develops products for the medical device and healthcare industries, with a focus on software. Ms. Masters provides systems engineering, project management and software leadership support to customers.

Systems Engineer for Wireless Body Fluid Sensor. Ms. Masters was the systems engineer and technical lead over six development partners for a startup company.  She was responsible for requirements, architecture, cybersecurity, and safety risk management in alignment with the FDA expectations.

Systems Engineering Team Augmentation. Systems engineering team augmentation for a complex electromechanical robotic device. Ms. Masters is responsible for implementing security and safety risk management and developing the system level requirements for the system. Ms. Masters is creating new processes and the plan for security, leading the security threat analysis for the medical device, and creating requirements to help secure the connected device. Ms. Masters also serves as a key technical reviewer in subsystem development and reviews. Ms. Masters is assisting with the development of new policy and SOPs at the corporate level while mentoring staff in the quality organization.  CMD is also leading the formative studies and research, assisting with the embedded software development, and assisting with the development of the marketing requirements.

Technical Lead for Medical Device. CMD served as the project manager and technical lead for a Class I mechanical device meant to assist amputees to learn to walk again more quickly and with a more natural gait. CMD created a regulatory strategy for the device and its various potential implementation considerations. CMD led the mechanical prototype design effort, and requirements and architecture development. This project is continuing into the next phase of design and development.

Systems Engineering Team Augmentation. Systems Engineering Team Augmentation for complex, electromechanical robotic medical device.  The project involves multiple companies working to develop systems meant to eventually integrate into a single, complex medical device.  Melissa assisted with the creation of a new team and discipline at the prime company while working on detailed planning and strategy. She led the effort to create cybersecurity process and policy within the prime and other organizations. She helped to architect and define secure solutions for one of the key wireless interfaces. She also assisted in the interface architecture and requirements between major subsystems, and system and subsystem architecture development compliant with electrical and software standards for safety.

Technical Documentation Preparation for NDA.  CMD is supporting a company with the preparation of technical summaries and documentation for their NDA submission of a radiopharmaceutical delivery system.  Melissa assisted in coordinating the technical summaries being developed by CMD for the company and is the primary author of some of the technical documentation.

Harmonized Requirement Process for Global Organization. CMD created a requirement process for a global organization with dozens of subsidiaries. This process harmonized the various company processes, recognized standards, and best practices. CMD is also working to achieve adoption and alignment of the process with subsidiary companies.

Device Secure Services. Operations Lead. Ms. Masters was the creator of BATTELLE DeviceSecure™ Services which was started to help identify and resolve potential cyber security threats and help companies navigate complex and evolving regulatory requirements and expectations. Ms. Masters implemented policy and procedures at major medical companies. Ms. Masters created a threat analysis technique that combined the CVSS standard with familiar medical device risk analysis techniques. Ms. Masters implemented this and oversaw this threat analysis technique on several medical device programs. This led to more secure software, hardware and embedded systems solutions in addition to identifying potential security vulnerabilities.  Ms. Masters also served as one of the team members and authors of the drafting and first release of TIR57: Principles for medical device security – Risk management.

NeuroBridge™ (now NeuroLife™). Ms. Masters was the co-creator, project manager, and systems engineer responsible for the creation of the NeuroLife product. NeuroLife is an external neural bypass technology that translates neural activity (thought) into movement of the wrist and hand. Ms. Masters led the team through prototype development. She worked with the Ohio State University medical team (Neuro-Surgeons, Administration, and Clinical Staff) to achieve FDA IDE approval and launch of the clinical study. Key project management responsibilities include managing the schedule, budget, and conducting earned value. System engineering responsibilities included system architecture, safety risk management, requirement analysis and definition, and verification planning.

Technical Oversight. Ms. Masters provided technical oversight and guidance to ensure programs are technically exceptional, meet or exceed requirements, including evolving regulatory expectations, and meet or exceed client’s expectations. Project oversight includes: blood glucose monitors, radiopharmaceutical infusion systems, auto-injector combination products, complex drug delivery system for neonates, heated humidification system, hand-held drug delivery inhaling system, Independent Feeding Device, NeuroLife neural bypassing technology, DARPA dialysis-like-therapeutic to treat sepsis among others.

External Peripheral Nerve Stimulator. Ms. Masters was the project manager and systems engineer responsible for an external peripheral nerve stimulator to be used in a clinical trial.  Key areas include project management responsibility include managing customer and team relations, schedule, budget, and conducting earned value. System engineering responsibilities included safety risk management, requirement analysis and definition, and verification planning.

Continuous Glucose Monitor for preclinical. Ms. Masters was the System Engineer on a device intended to be used in a preclinical trial in harsh conditions. Ms. Masters was responsible for requirements analysis and definition, system architecture and verification planning. Ms. Masters also assisted with project planning, schedule and status.

Sensor for Detection of Subcutaneous Changes in Human Tissue. Ms. Masters has conducted laboratory investigation, performed analysis through electromagnetic software simulations, and has written Matlab code to perform analysis and post process data. She has also written test procedures and technical reports.

Project Management. Ms. Masters implemented processes and project management techniques into a fast-growing venture capital-funded company. Ms. Masters managed multiple software projects simultaneously. These projects encompassed Search Engine Optimization, publishing millions of pieces of content, database management, and web-site development.

Game Phone. Ms. Masters led a cross-functional team that created an accessory prototype utilizing a new form factor for a cellular phone using accelerometers. Motion was translated into an action or button push in a cellular phone. This prototype concept was awarded Motorola iDEN’s Think Tank Idea of the Year by Motorola executive and senior management.

Software Engineering. Ms. Masters has executed in-depth software analysis with a logic analyzer to determine software timing to increase productivity for peak performance. Ms. Masters has also developed DSP code, simulations and tests for a long-range infrastructure-free walkie-talkie device. She has also performed software configuration management, debugged software in embedded devices, and worked with iDEN, CDMA, and TDMA technologies.