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.
• 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.
• 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.
• Regularly presenting to C-suite, providing updates on progress, milestones, challenges, and sensor process/mfg updates

- 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.

- 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.

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.

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.

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.
• 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.
• 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.
• 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.

-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.

• 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