Systems Engineer Computer

Successful leader with a proven history of over ** plus years of IT experience in various IT

positions along the SDLC process (Waterfall/Agile/Hybrid-methodology). IT professional with

extensive experience providing support and direction in the development and deployment of

computer systems, IT strategy, and multimedia design. Proven ability to manage multiple

projects with competing deadlines and priorities while ensuring adherence to various budgets and

timelines. This unique knowledge, education & experience adds to effective understanding

and successful execution for any position in the IT SDLC process.

PROFESSIONAL EMPLOYMENT EXPERIENCE

Karsun LLC June/2021- March/2025 Herndon, VA

Federal Aviation Administration (FAA Contract/Clearance-Public Trust)

Solutions Architect/Acquisitions Analyst/ Systems Engineer

Provided acquisition support for Federal Aviation Administration (FAA) Facilities & Equipment (F&E) division. Provided program organizations and development teams with technical review and improvement of key concepts, technical planning and implementation. Reviewed & approved documentation (SAR, ConOps, FAD, ISPD, PRD) compliance with the FAA Acquisition Management System (AMS)

Provided support to FAA governance and compliance bodies (FAA Enterprise Architecture Board - FEAB/Architecture Review Board - ARB) to maintain and improve program management, product life-cycle policies, guidelines and standards

Collaborated with FAA Enterprise Architects to assess proposed program/project's impacts

on overall mission and objectives. Reviewed proposed system changes and performed

assessments to determine the extent of assessment impact

Restructured, implemented, reviewed and updated documentation for FAA F&E investments going through the FAA AMS phases (CRDRD, IARD, IID, & FID)

Developed the annual FAA F&E Enterprise Roadmaps. Updated & compiled the stakeholder’s data into the annual F&E Roadmaps

Facilitated meetings with stakeholders to capture, assess and review project concepts, strategies, plans, and requirements, for investment projects and for product sustainment efforts

Developed, improved & maintained robotic process automation for weekly senior management, status reports, project scheduling & other ad hoc reporting using UIPath, Power Apps, Power BI, Microsoft Power Automate software and advanced excel reports

SENSEONICS INC March/2020–June/2020 Germantown, MD

Software Quality Assurance Engineer

Evaluated proposed changes to computer systems and recommended level of validation activities required for software quality compliance

Developed software specifications for validation requirements and to ensure that those requirements are testable, and 21 CFR Part 11 compliance

Developed CFR Part 11and ISO 13485 based computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ/PQ protocols and all related documents, and deliverables within the scope of the validation plan

Identified and qualified all computer systems which impact operations using a risk-based methodology

Developed, maintained & managed executed test plans, test scripts and user acceptance tests (UAT)

SURGISENSE CORPORATION April/2015-March/2020 Bethesda, MD

Computer Systems Engineer – Quality Assurance

Project lead for the customization of the PTC Windchill and Integrity systems, and related system validation activities, aimed to optimize project and software development management capacity and regulatory compliance

Developed and implemented the policies and procedures for backup, security, and network use. Maintained documentation ensuring adherence with required regulatory agencies

Provided technical support for remote connection issues (VPN, RDS), and mobile connections, as well as general hardware and software end user support

Monitored and maintained network availability and efficiency using network monitoring tools such as Wireshark, Cisco CLI, Cisco Firepower, Microsoft Event Viewer, and PowerShell scripting

Implemented and maintained local domains, including the use of Active Directory databases and policies.

Created Computer System Validation procedure documentation, ensuring compliance with validation plans and deliverables aligned to current GMP’s regulations

EDUCATIONAL EXPERIENCE

STRATFORD UNIVERSITY Falls Church, VA

Master of Science, Software Engineering – 2016

EMERSON COLLEGE, Boston, MA

Master of Fine Arts in Media Art & Technology – 2014

BERKLEE COLLEGE OF MUSIC Boston, MA

Bachelor of Fine Music in Contemporary Writing & Production – 2011

UNICEUB Brasilia, Brazil

Undergraduate Computer Engineering Courses – 2007

PROFESSONAL CERTIFICATIONS

AWS Partner: Cloud Economics Accreditation, Amazon Web Services, Feb 2023

AWS Learning: Architecting, Amazon Web Services, Feb 2023

Certified SAFe® 6 DevOps Practitioner, Scaled Agile, Inc., Apr 2023

Certified SAFe® 6 DevOps Practitioner, Scaled Agile, Inc., Apr 2023

Penn State University Certification in C programming– January 2020

Udacity Cloud Engineer Certification – October 2019

Apple Mobile Certified Technician – December 2018

BSI Certified Lead Auditor - Management Systems Audit Teams, February 2016

BSI Certified Auditor - Management Systems Audit Teams, February 2016

BSI Certified – Medical Device Management Systems - ISO 13485, February 2016

CFPIE Validation of Computer Systems, March 2016

Certifications in Administration of PTC Integrity and Windchill, January 2015

Certified in Risk Management for Medical Devices and ISO 14971, June 2016

Microsoft Certified Professional, EMC2 Certified Professional, March 2003

EMC2 Storage Fundamental Certified Professional

Microsoft – C++ Programming Language

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