
Samantha Mosher
Research And Development Engineer @ Radical Catheter Technologies
About
R&D engineer specializing in medical device development, with experience spanning full product lifecycle execution — from concept and rapid prototyping through design freeze, V&V, and 510(k) FDA submission. Currently serving as project manager and lead engineer on a Class II catheter device program at Maduro Medical, where I work on end-to-end development including pilot line management, design controls, and regulatory submissions. Previously at Penumbra Inc., I contributed to the development, 510(k) clearance, and commercial launch of a novel medical device (Ruby LP System), and advanced a second device through design freeze and Phase I (Ruby XL System). My background also spans neuromodulation research at Northeastern University's Brain Stimulation & Simulation Lab, where I conducted computational modeling (FEM/SimNIBS) and administered clinical trials for transcranial electrical stimulation therapies — work that continues to inform how I think about device-tissue interaction and therapeutic mechanism. Earlier co-op experience at Arsenal Medical and Lyndra Therapeutics grounded me in biomaterials, formulation science, and scale-up in fast-paced startup environments. 📁 Portfolio: https://moshers.wixsite.com/smosherportfolio/projects
United States
San Francisco
Hospital & Health Care
Aeroponics, Mechanical Engineering, 3D Printing, Rapid Prototyping, Bioreactor, Materials Science, Experimental Design, 510(k), Technical Documentation, ECO, Data Analysis, Chemistry, Product Development, Good Manufacturing Practice (GMP), Research, Teamwork, Finite Element Analysis (FEA), High-Performance Liquid Chromatography (HPLC), Cell Culture, Assay Development
Experience

Research And Development Engineer
San Francisco Bay Area
Serve as Project Manager and lead engineer for a Class II medical device, advancing the program from early prototypes through design freeze, GLP animal studies, and V&V as part of an FDA submission. Drive systems-level decision-making by coordinating cross-functional inputs, managing requirements, risk analyses, and design documentation in a fast-paced startup environment. Manage a pilot manufacturing line, establishing build plans, resolving technical and design issues, ensuring documentation accuracy, and delivering high-quality units to support project milestones

Research Assistant
Boston, Massachusetts
Conducted groundbreaking research on the effects of electrical therapies on the brain through FEM, gmsh, SimNIBS, and Seg3D modeling and simulation. Administered and managed clinical trials, demonstrating excellent organizational and interpersonal skills in handling recruitment, phone screening, psychological evaluations, MRI scanning, transcranial electrode stimulation, and computer modeling. Contributed to background literature reviews and pending paper publications.

Research And Development Engineer 1
San Francisco Bay Area
Led development of a novel medical device product line through in silico, in vitro, and in vivo modeling, project planning, rapid prototyping, and data analysis. Contributed significantly to design finalization, formal testing, and documentation for an FDA submission, leading up to a product launch. Demonstrated strong project management skills while handling sourcing, material stocks, and supplier relations.

R&D Co-op
Boston, Massachusetts, United States
Formulated and tested medical device product for in vivo animal studies, analyzing in vitro rheometer and Instron data to determine material properties for final formulation selection. Designed, optimized, edited, and documented test methods in collaboration with the manufacturing and quality team for approval, ensuring compliance with industry standards. Supported scale-up and de-risking experimentation to advance the product towards clinical trials. Maintained the lab space and played an essential role in managing purchase orders.

NUStart Peer Mentor
Virtual
Provided individual and group mentorship and connection opportunities for first year Northeastern University students living all across the globe who could not be on campus due to COVID-19. Worked with other peer mentors and instructors to create lesson plans for the upcoming week.

Formulation Co-op
Lyndra Therapeutics
Watertown, Massachusetts, United States
Developed formulations of numerous drugs for Lyndra's unique extended-release pill, showcasing a deep understanding of materials and their interactions with pharmaceutical compounds. Led formulation development and testing with a specific base polymer and drug pairing, contributing to the enhancement of product performance.

Medical Scribe
Documented the details of the patient visit from initial intake to final diagnosis using the EPIC software in order to assist medical professionals including physicians and physician assistants. Developed understanding of medical terminology, diagnostic tools, orders, interventions, and general hospital workings.

Medical Experience Academy Student with Prisma Health Tier 2
MedEx Academy Tier 2 is an educational summer program where I shadowed physicans for approximately 80 hours as well as learned about a wide variety of medical professions and participated in formal medical ethics debates.

Camp and Lab Assistant with Roper Mountain Science Center
During the summer, I helped provide instruction to campers and visitors in a range of science based activities and experiments, ensured safe and properly prepared environment for such activities, and worked with a team of other assistants to prepare for and organize supplies for all events.
Samantha Mosher's Contact Information
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