Ensuring the team has the resources they need to get the job done in a way that provides a sense of purpose, community, and growth.

Support clients on human factors, device engineering, compliance, commercialization, and manufacturing challenges related to pharmaceutical, combination, and medical device products.• Lead preparation and execution of human factors formative testing.• Support execution of human factors validation testing. • Support ideation and implementation of human factors regulatory strategy. • Author Use Specifications, Use Task Analyses (UTAs), Comparative Analyses (CA), Known Issues Reports, Use-related Risk Analyses (URRAs), Use Failure Mode and Effects Analyses (uFMEA), and Human Factors/Usability Engineering Summary Reports in support of FDA submissions and maintenance of Usability Engineering Files (UEFs) or Design History Files (DHFs).• Support User Interface (UI) design and development for combination products and stand-alone medical devices• Develop protocols and provide engineering oversight for design verification testing. • Implement design controls and risk management processes across a portfolio of combination product and medical devices.• Support development of technical design controls documentation to ensure regulatory compliance to relevant local and federal regulations.• Conduct gap assessments for regulatory standards including 21 CFR Part 820, IEC 62366, IEC 62304, ISO 14971, and the EU MDR. • Design and deliver internal training on applying the human factors/usability engineering process to medical devices and combination products. • Support execution of equipment qualification

Assisted between university classes and during academic breaks in the development of a novel device for label-free molecular binding quantification.Roles/Responsibilities included:• Designed and executed experiments related to fluidics, molecular binding quantification, and optical systems• Designed in SolidWorks for additive manufacturing in order to produce testing apparatus• Programed electro-mechanical subsystems that combine robotics and fluidic pumps• Analyzed fluidic and optical data in order to establish device performance• Visualized datasets in order to communicate experimental conclusions to supervisors• Authored WIs related to device operation and chemical reagent testing• Applied user centered design principles to software requirement ideation and implementation

Performed market research concerning respiratory combination devices to assist the ProcessChemistry Department.• Performed landscape assessments for nebulizers, dry-powder inhalers, and metered dose inhalers in support of commercialization strategy• Collected and visualized data in excel resulting in presentation of findings to department directors• Established candidate device specifications and attributes by literature and public documentation review

Mastered rope splicing and tensile testing techniques in order to produce consumer and militarygrade rope assemblies used by the US Armed Forces and the commercial shipping industry.• Tested assemblies in compliance with QC standards for tensile strength, elongation at failure, and ultimate strength up to 400,000 lbf• Operated testing equipment for cyclic loading and break testing of synthetic rope assemblies• Followed standard protocols to encase synthetic rope assemblies with abrasion resistant polymer coatings• Spliced synthetic rope in support of helicopter reach pendant manufacturing