Madeline Desenna Email & Phone Number

San Francisco Bay Area

• Led cross-functional team in execution of Design Control deliverables resulting in FDA 510(k) clearance of large bore catheter for neurovasculature access. Project was executed in a six month timeline (Feb-Jul 2023).• Directing a team in the design of a next generation reperfusion catheter for navigating the neuroanatomy and removing blockages. Successfully executed the feasibility phase resulting in an approved proof of concept design. Coordinated the implementation of new processes involving design input requirements and risk documentation.

San Francisco Bay Area

• Led activities in support of multiple R&D projects; optimizing hydrophilic coating, creating artificial radiopaque clot model, designing specialized in vitro test models, and developing test methods.• Led a team in execution of a multi-physician design validation simulated use testing resulting in validation of a combination device on the first attempt. Authored test protocol and report for design validation and collaborated with multi-disciplinary team to release documents on schedule. • Managed and executed multiple successful demonstrations with practicing physicians, fellows, internal sales team, and investors. Through an effective physician demonstration, combination device is currently being presented to an international review board for first in-human clinical trial due to overwhelmingly positive physician experience. • Planned and executed a seamless 32-animal GLP study to prove safety and efficacy of combination device.• Designed and executed testing to generate marketing claims.

San Francisco Bay Area

• Responsible for designing and overseeing all aspects of physician evaluations and translating physician feedback to the design team, some of which led to critical design changes involving radiopacity and the delivery system. • Researched, designed, and generated validation models and clinical specifications for implants and delivery systems.• Early feasibility and down selection of 15 biocompatible coatings, including in-vitro, ex vivo and in-vivo testing. Testing consisted of various blood flow loops (bovine, porcine, rabbit and baboon), emboli evaluation, particulate testing optimization, simulate use testing and elution evaluation.

Boulder, Colorado

Full-time Inter for Biodesix CLIA Assay Development Team; work safely with clinical samples and management of databases while performing molecular biology lab techniques such as NGS and qPCR, along with quantitative and qualitative testing; development and improvement of new product concepts; data retrieval and organization for regulatory submissions; data analysis followed by formal reports and presentations; generation of a learning platform for the development of serum-based proteomic test addressing critical oncology questions.

Lawrence, Kansas Area

Volunteered to assist Dr. Stevin Gehrke in the Polymer Lab at the University of Kansas; manufactured polyethylene glycol diacrylate (PEGDA) hydrogels with vitamin B12 incorporated; diffused B12 out of the hydrogels using a solvent of water; analyzed diffused material with mass spectroscopy to obtain diffusion coefficient of hydrogels; formally presented data to graduate students.

Lawrence, Kansas Area

Tutor to freshman engineering student for math, chemistry, biology and physics.

Lawrence, Kansas Area

Assisted Dr. Arghya Paul at the University of Kansas in the BioIntel Lab studying tissue engineering; collaborative process development and documentation; produced gelatin-alginate hydrogels for bone tissue generation and cell therapy; tested hydrogels’ mechanical and biological properties; coated hydrogels with human stem cells and tested durability of stem cells on the hydrogels, prepared formal report over findings.

Bachelor Of Science - Bs, Chemical Engineering

Education record