Edwin Almeida Email & Phone Number

United States

Chevy Chase, Maryland, United States

• Prepare submissions and reports for regulatory agencies and notified bodies for the release of a novel medical device (surgical grade portable nitrogen dioxide-based sterilizer to increase access to essential basic.
• Successfully submitted 510k device submission to the FDA and interface with regulatory agencies.
• Design and implement protocols for product specifications, testing, quality, risk management, human factors and usability engineering, verification, and validation in accordance with current industry guidance.
• Manage document control and maintain quality management system in accordance with ISO 13485:2016 and 21 CFR 820.
• Participate in project team meetings to plan strategies and review product specifications and requirements on testing.
• Coordinate with intellectual property and patent attorneys to draft submissions and maintain trademarks.

Washington, DC

• Provide clients with support for regulatory affairs as well as assistance for the development, implementation, and optimization of robust strategies including submissions and reports for regulatory agencies and.
• Prepare submissions for new and current products and their changes as required by the FDA and regulatory agencies.
• Evaluate and maintain quality management systems, manufacturing, design, facility and material controls, supply chains, supplier records, corrective and preventative actions, internal and external audits, laboratory.
• Review scientific data submitted in support of a variety of medical device submissions to determine the safety and effectiveness of processes and materials used in the manufacture and testing of medical devices or.
• Document required evidence and data to support violations noted during inspections and investigations.
• Provide internal and external stakeholders outreach, assistance, and education, and mentor less experienced personnel.

Frederick, Maryland, United States

• Managed the Reconstructive Transplant Research Program (RTRP), Peer Reviewed Orthopaedic Research Program (PRORP), and Orthotics and Prosthetics Outcomes Research Program (OPORP), under the Congressionally Directed.
• Administered and led panel of subject matter experts to conduct programmatic review and vision setting meetings.
• Drafted scientific materials, project metrics, research highlights, lived experience highlights, and meeting summaries.

Alexandria, VA

• Conducted substantive examination of patent applications in the field of Biomedical devices with emphasis in physical therapy and respiratory appliances.
• Prepared scientific reports for Patent Attorneys that clearly evaluated and explained problems within an application.
• Executed scientific meetings with applicants and Patent Attorneys, recorded, and summarized critical information.
• Reviewed and researched policies and procedures from patent case law to process cases accurately.

Coral Gables, Florida, United States

• Automated a behavioral method to reduce variability and human error during neural recordings in primate research laboratory by designing and building a device using 3D modeling and 3D printing.
• The device resulted in increased efficiency and effectiveness in the field of traumatic brain injury research.

Johnson & Johnson 3D Printing Center Of Excellence - Umiami

• Optimized titanium and stainless-steel alloy 3D printing system parameters by executing experiments for the analysis of mechanical characteristics through tensile, hardness, and density testing as part of the research.
• Drafted and implemented Standard Operating Procedures (SOPs) to characterize metal powder alloys for Direct Metal Laser Sintering (DMLS) 3D Printing through literature reviews and experiments in accordance with ASTM.
• Drafted and implemented SOPs for industrial hygiene and/or environmental risks, including regulatory compliance and job safety analysis.
• Reviewed design specifications and other technical documents and provided training and support to other members of the department.

Hecht Residential College

• Created a comprehensive “first year experience” to assist residents with transition to university and residence hall life while creating lifelong memorable experiences and fostering positive engagement on campus.
• Interacted with residents daily and interfaced with parents of residents during move-in and move-out days.
• Hosted, organized, planned, and supervised monthly themed social events for the residents surrounding various activities facilitating a fun and educational experience for the building.
• Collaborated with management team to design programming promoting both social and academic excellence.
• Delivered the highest possible standard of consistent, proactive, and professional service while serving as a campus leader and treating residents with poise and respect.
• Served as a public face of both the building and the university while working shifts at the front desk answering questions with the highest knowledge of campus and community information.

Bethesda, Maryland

• Maintained QMS and product files to support compliance with regulatory requirements (FDA/EU MDR CE).
• Generated and implemented SOPs for testing and quality assurance of surgical grade portable nitrogen dioxide-based sterilizer to increase access to essential basic surgery in low-resource and/or remote environments.
• Delivered and reviewed design specifications and other technical documents to research and development team and chief company executives.
• Identified and reviewed scientific literature and historical data to ensure successful implementation of product design.
• Reviewed and practiced FDA laws and regulations, administrative policies, good manufacturing practices, guidance documents, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards.

University Of Miami

• Designed testing methodology in EPrime Software to monitor patterns and discrepancies in electroencephalograms (EEG )
• Processed data using MATLAB assisted source localization and signal processing techniques

University Of Miami

• Designed instrumentation methods for diagnosis, rehabilitation, and therapy of hearing disorders and deafness
• Monitored patterns and discrepancies in brain waves, speech patterns, and visual evoked potentials

Fairfax County, VA

• Contributed general contracting and construction services for upwards of 100+ clients.
• Assembled and installed furniture and appliances for both professional and residential spaces.
• Served as a team leader organize work force and delegating tasks.
• Increased productivity and overall revenue by 25% for the company.

Master'S Degree, Biomedical Engineering

Activities and Societies:Master's Design Project: - Work with Dr. Abishek Prasad in the Neural Interface Lab

Bachelor Of Science (B.S.), Biomedical Engineering

Activities and Societies: • Horizons 2015 Orientation Leader • Alternative Breaks Service Volunteer (UMAB) • Volunteer Site Leader for.

Bachelor Of Engineering (B.E.), Engineering

High School Diploma, High School

Activities and Societies: National Honor Society, National Spanish Honor Society, National Science Honor SocietyInternational.