Brian Mcgee Email & Phone Number

Danvers, Massachusetts, United States

Danvers, Ma, Us

Goleta, Ca, Us

• Leading the formation of the manufacturing and process development teams at Laxmi through the creation of roles and responsibilities, onboarding, mentoring, and coaching of new hires, and setting yearly goals and objectives for all direct reports• setting up a facility including 2400 sq feet of cleanroom space to work through technical development of a novel glucose sensor while adhering to quality and regulatory compliance• Developing and maturing processes for application of chemistry layers comprised of enzyme and membrane solutions to develop an innovative glucose sensor aimed at being more accurate and comfortable to wear than competing on-market products• Managing budgets, timelines, and resources for start-up business to balance spend with long-term strategic goals of the organization• Establishing infrastructure and requirements to be ready for pivotal study including qualification of equipment procedures/controls, preventative maintenance of equipment, setting up systems for product traceability, and creation of initial quality and design control documentation• Regularly presenting to C-suite, providing updates on progress, milestones, challenges, and sensor process/mfg updates• Collaborating cross-functionally to align on high level presentations for the Board of Directors to demonstrate the advancements through product development• Influencing cross-functional teams to drive problem solving across all areas of product development including mechanical design and chemistry to ensure design for manufacturability• Leading the establishment of a facility for glucose sensor manufacturing in a clean room environment, which is comprised of areas for wafer fabrication, electroplating, chemistry application, laser cutting, assembly, and mechanical testing• Presiding over the day-to-day operations of the manufacturing site, driving process development, manufacturing tools and systems, and quality compliance to prepare Laxmi for pivotal studies

- Managing a team of supervisors, engineers, chemists, and assemblers accountable for next gen product transfer from R&D and successful world-wide launch.- Develop processes and design equipment to facilitate chemistry application for glucose sensor manufacturing, managing capital to revolutionize manufacturing of on-market product to increase throughput, yield, quality, and efficiency; decrease cost, time of manufacturing, and scrap to empower operators to continuously improve- Working along-side R&D for design transfer to manufacturing for next generation products, including process development, process improvement, scale-up, and product design for manufacturability- Implementing a re-structure of the manufacturing line through equipment changes, culture changes, and LEAN/DMAIC approach(es)- Establish and manage timelines, budget, and strategy for meeting deliverables around risk mitigation, pilot line use, a new manufacturing line, submissions and implementation/launch- Continuously improve product performance and processes - Manage relationships closely with R&D, Regulatory, Quality, Supply Chain, Quality Control/Affairs, Receiving/Inspection, MRB, multitude of vendors, in-house clinical affairs, and Marketing teams on future product and technology evaluation

- Lead a team to support the fabrication of five product lines of medical devices ensuring quality of product, delivering on process and product improvements, product transfer, and preparation for FDA and GMED submissions/approvals- Provided guidance, direction, and support to supervisors, engineers, chemists, technicians- Collaborated with regulatory, quality, R&D, marketing, and senior leadership to establish momentum and finish projects critical to quality, cost, and pipeline efforts- Maintained and supported manufacturing needs post launch of new product lines during scale up and quality improvement efforts- Built culture change and improvement throughout manufacturing organization

Led a team of engineers and chemists in achieving the responsibilities of manufacturing continuous glucose sensors, continuously improving sensor performance and processes, monitoring in-vivo and in-vitro data, increasing throughput, monitoring FDA and GMED requirements and guidelines as they pertain to our product, validation of equipment and processes (IQ, OQ, PQ), CAPA coordination and execution, and other responsibilities. Managed a team to accomplish myriad goals while adhering to schedule and budget requirementsWorked to maintain quality of product while achieving increased throughputStrived to increase capacity from several thousand parts per week up to 100,000 parts per week while maintaining the quality of the product and functionality as it was designed.Traveled to locations such as Puerto Rico and Bogota, Colombia to maintain production sites and relationships with physicians and customers.

Worked with the continuous glucose sensor R&D team on the current sensor and developing next generation sensors:These projects involved hands-on experience with enzyme driven sensor design, prototyping sensors involving newchemistries and their various methods of application, developing novel approaches to improving current output, stability, and drug interference present in the current sensor. Detailed attention was paid to substrate, biochemical,electrical, and fabrication influences on in-vitro and in-vivo data analysis in preparation for subsequent revisionsof the sensor. Gained extensive clean-room experience, including use of myriad machines, small robots, processes, and fabrication techniquesTechnical writing and author of engineering reports, procedures, and reference documents during developmental processto ensure proper documentation, adequate documentation of research and design performed, and in preparation of submission to departments such as quality, and institutions such as the FDA.Obtained extensive experience in product development, as well as crucial validation requirements including IQ, OQ, and PQ execution, fault analysis, mitigation, and report preparationLed engineers and interns in problem solving and product development involving crucial processes and chemistries critical to achieving desired product performance and satisfying strict and tight timelines.Led efforts to scale up aforementioned glucose sensor involving an entire new fabrication line in a new segment of the cleanroom. Led engineers on continuously improving the glucose sensor through process improvements, design changes, and new technology.Met demanding schedules for validation activities and preparation for FDA, GMED, and other device and quality related submissions.

Minneapolis, Mn, Us

• Worked with the continuous glucose sensor R&D team on the current sensor and developing next generation sensors: These projects involved hands-on experience with enzyme driven sensor design, prototyping sensors involving new chemistries and their various methods of application, developing novel approaches to improving current output, stability, and drug interference present in the current sensor. Detailed attention was paid to substrate, biochemical, and electrical design, and fabrication influences on in-vitro and in-vivo data analysis in preparation for subsequent revisions of the sensor.• Carried out all necessary research, characterization, and development leading up to full validation of a next generation sensor including in-house feasibility data, and sensor fabrication for a clinical/pivotal trial which led to the approval outside of the United States of America, subsequent launch, and preparation for submission to the FDA.• Gained extensive clean-room experience, including use of myriad machines, small robots, processes, and fabrication techniques• Technical writing and author of engineering reports, procedures, and reference documents during developmental process to ensure proper documentation, adequate documentation of research and design performed, and in preparation of submission to departments such as quality, and institutions such as the FDA.• Obtained extensive experience in product development, as well as crucial validation requirements including IQ, OQ, and PQ execution, fault analysis, mitigation, and report preparation• Led engineers and interns in problem solving and product development involving crucial processes and chemistries critical to achieving desired product performance and satisfying strict and tight timelines.

Explored innovative technologies and their applications to evaluate their possible use in the design of a new product. This investigational work included extensive research into the technology as well as physical use with the product to determine its functionality, compatibility, and sensitivity with the current sensor.Collaborated with an outside company regarding relevant technologies and its application to our product development.This relationship was initiated due to their familiarity with the technology and by the desire to explore alternative methods of introducing the product to Medtronic’s continuous glucose sensor.Characterized electroplating procedures as they pertain to platinum deposition on electrodes through several quantitativeand qualitative diagnostic tests used in the laboratory such as cyclic voltammetry / surface area calculations, SEM imaging, and statistical analysis.Gained invaluable knowledge, insight, and experience into the corporate R&D industry of medical devicesAffirmed my passion to work with a team to develop products that will improve peoples’ lives

-Researched and learned the mechanical process, physics of, and operation of ECG and Near Infrared Spectroscopy for a laboratory procedure-Performed and carried out a protocol to electrically stimulate rat while sedated, via electrical stimulator in order to obtain data regarding brain function and activity by use of near infrared spectroscopy and the resulting change in the subject's ECG signal-Performed anesthetic procedures with syringe and various chemicals including urethane and alpha-beta-chlorolose. -Performed research on human subjects using near infrared spectroscopy (NIRS) & force transducer. -Performed & carried out protocol requiring subjects to contract anterior tibialis with NIRS connected. By pulling back with their anterior tibialis, they produced a force that was read by the force transducer and amplified through a bridge circuit. I wrote and used matlab code to analyze the data - observing trends in total hemoglobin, deoxyhemoglobin, and oxyhemoglobin.

• Hall role model, mediator, and supervisor• Build community, provide programming, ensure stability and policy enforcement• Work with entire housing staff as RA and more-so as HR to ensure all policies are being enforced and to approach any issues regarding staff and/or residents and students• Check in and out all residents• As HR, provide and create schedules for RA staff working under me, hold and attend weekly meetings pertaining to issues at hand, future planning and programming, and university happenings

Masters Of Science, Biomedical Engineering - Medical Devices And Diagnostic Engineering (Mdde)

Masters Of Biomedical Engineering

Bachelor Of Engineering, Biomedical Engineering

Bachelor Of Engineering, Biomedical Engineering