• Maintain ownership of risk management and design and development activities for a Class II medical device.• Launch product design & development process, including product traceability, verification & validation, and design transfer.• Initialize and manage engineering change management activities.• Identify areas for continuous improvement and CAPA. • Author internal company documentation such as work instructions, manuals, test protocols, and training presentations.• Create comprehensive and understandable device documentation for technicians, users, and customer service representatives.• Perform internal auditing in regulation with 21 CFR 820, ISO 13485:2016, ISO 14971:2019, CMDCAS, and MDSAP.• Overhauled Design and Development and Risk Management procedures, created traceability matrix form and process, implemented computer system validation process, saw class II products through multiple design transfers and FDA Letters to File.

• Work with authors to find their hype crew of readers to promote their books.• Set up cover reveals, book features, book review tours for books across various genres.• Create social media content (static posts, slideshows, and reels) for authors.• Manage Instagram and TikTok accounts for authors.• Aid authors in book launches, including advance reader copy (ARC) management.

Review and promote books on social media and on retailer sites, including:• Instagram: https://www.instagram.com/emilyisoverbooked/• TikTok: https://www.tiktok.com/@emilyisoverbooked• Goodreads: https://www.goodreads.com/emilyisoverbooked• NetGalley

• Managed social media accounts for a clinical trials SaaS technology company.• Created, updated, and evaluated website content and blog posts (in WordPress) for mHealth in clinical trials to drive website traffic.• Formulated SEO-optimized blog post ideas and outlines related to clinical trials.• Wrote press releases to announce new technology for use in the medical field.• Updated, edited, and wrote marketing material for companies in medical, insurance, and pharmaceutical fields.• Revised service manual for a medical device letter to file.• Updated and wrote work instructions for medical devices and software.• Edited content for eBook Clinical Trials Patient Recruiting and Retention (Tips for Success) (2014).• Optimized User Manual for organ donor matching software by authoring new text, editing existing text, and formatting document.• Created a Functional Specification document for organ donor matching software.• Crafted research and validation section of business plan for a medical device used during colonoscopies.

Technical Writing:• Regulated software documentation, including functional specifications, traceability matrices, and test script documents, across multiple software projects for clinical trials SaaS software.• Performed quality control in an agile environment by writing test scenarios to cut testing time in half.• Authored manual OQ test scripts.• Authored, edited, and organized SOPs and internal training documentation.Quality Assurance:• Executed manual and automated (Cucumber and RSPEC) quality testing to validate software functionality for all company projects.• Assigned testing and quality tasks to entry-level testers.• Used Atlassian tools (Confluence and JIRA) to manage SDLC.• Assigned employee training and aided in oversight of training compliance.• Participated in Process Improvement to increase success in future releases and projects.• Reported and handled CAPAs.• Aided in external audit preparation by pharmaceutical clients.Marketing:• Managed Verdacom’s social media accounts (Facebook, Twitter, LinkedIn) and blog.• Created marketing material and presentations to successfully communicate company services.Project Support:• Oversaw all project support requests, assigning and investigating tickets to enhance user experience.Project Management Assistance:• Managed Agile boards by creating and organizing sprints and creating issues.• Ran planning and closeout meetings with the client.• Planned testing procedures for use in client User Acceptance Testing (UAT) and Performance Qualification (PQ).

• Authored functional specification, design specification, and traceability matrices across multiple software projects for clinical trials SaaS software.• Wrote and executed manual test script documents for all company projects.• Used Atlassian tools (Confluence and JIRA) to manage SDLC.

• Designed promotional materials for events and conferences. • Managed social media accounts.• Authored newsletter to update city-wide donors on ministry events. • Aided in the organization of seasonal events and conferences.

• Completed protocol-specific clinic visits for over 20 different phase II - IV clinical trials, taking blood pressure, recording AEs / SAEs, dispensing drug, and recording patient data.• Recruited patients for studies and set up patient visits for site clinical research staff.• Processed and shipped laboratory specimens for all studies on site.• Received special recognition and a raise after completion of 90-day training program.

• Planned and executed laboratory exercises for 30 students in areas related to ECG, EMG, EEG, algorithms, signal processing, and business.

• Researched ultrasound and performed sonography on ten patients using a Siemen’s Acuson P50 ultrasound machine for a pre-FDA clinical study.• Authored narrative and created illustrations for an executive business plan.

• Studied the effects of damage to the visual cortex in abolishing the N2 component of the motion-onset visual evoked response in humans performing a visual task.

• Acquired EMG signals from both stroke and non-stroke subjects and analyzed EMG signals in EMGWorks and MATLAB to help develop an algorithm for detecting foot drop.