Medical Device Software Engineer

Claude Asamoah

(Atlanta, GA)

Summary:

Highly skilled Software Engineer with extensive experience in software validation, medical device compliance (ISO 13485, IEC 62304), API testing, and quality assurance.

Proven expertise in manual and automated testing, test framework development, and backend validation for medical device software and mission-critical systems.

Strong background in CI/CD pipelines, DevOps, and regulatory audits, ensuring compliance with FDA and industry standards.

Adept at collaborating with cross-functional teams to deliver high-quality, reliable software solutions.

Proficient in Python, Java, SQL, Postman, Selenium, and Azure DevOps

Skills:

Software Engineering

Software Validation

Cyber Security

Attack Surface Management

Vulnerability Assessment

Penetration Testing

Medical Device

ISO 13485, IEC 62304

Quality Audits

API testing

Back-End testing

Manual Testing

Education:

Brandeis University, Waltham, MA

Master of Software Engineering

Tufts University, School of Electrical Engineering and Computer Science, Medford, MA

B.S. Engineering

Benjamin Franklin Institute of Technology, Boston, MA

A.S. Electronic Engineering Technology

Technical Skills: Oracle, DB2, MS SQL Server, MySQL, Excel, Word, PowerPoint, MS Project, Visio, VB6, VBA, C, C#, Java, SQL, PL/SQL, ASP, PHP, JSP, VBScript, JavaScript, CSS, HTML, HTML5, XML, UML, Shell Scripts, Python, JIRA, Cucumber, Groovy, Selenium, NUnit, JUnit, Coded-UI, ISO-9001/9002/14971, IEC 62304/82304, SPC, TQM, Test Automation, Docker, Postman, DevOps, NodeJS, VSCode, JAMA, API testing

Experience:

Emory University, Goizueta Business School Executive Education Aug 24 – Nov 24

IT Consultant, Atlanta, GA

Perform IT consultancy services such as the design and development of automated solutions for the Manager, Emory University, Goizueta Business School Executive Education.

Design solutions to reduce the amount of manual data entry in the process in-order to increase efficiency and data accuracy.

Determine better ways to enter and create the data needed to price, pay, and report program financials.

Created automated budget solutions using Excel and Word visual basic applications (vba) code.

Full Spectrum Software, Southborough MA Jun 2022 – Oct 2023

Principal Verification Engineer

Reviewed requirements specification and traceability and developed test plans.

Estimated, planned, developed, executed, and maintained manual test cases and test protocols for products under development.

Performed Software, API, GUI, and Back-End testing of medical device software.

Performed API testing using Postman and NodeJS.

Used Azure DevOps for software builds, releases, CI/CD pipelines, test management, and test metrics dashboards

Worked with project management to meet the testing milestones and deliver high quality solutions on time.

Performed Internal Quality Audits on the company’s programs and procedures to ensure that they conform to established company SOPs.

Ensuring that FDA-regulated medical products are tested in adherence to the applicable standards, regulations (ISO 13485, IEC 62304) and best practices.

Raytheon Technologies, Andover MA Mar 2019 – May 2022

Principal Systems Engineer

Created test automation scripts using Python and Squish IDE to test Command & Control software.

Created CI/CD pipeline to test Command & Control software using Jenkins.

Wrote testcases and performed manual tests on Command & Control software

Planned testing schedules, analysed, and mitigated risks.

Established and operationalized identified tools and processes to integrate, test, and validate advanced systems, hardware, software, and processes for optimum delivery.

Created Test Plans and Test Procedures for advanced systems integration, and test (SI&T)

Performed SI&T on advanced systems.

Active member of Artificial Intelligence (AI) and Semantics Technologies Technical Working Group (TIG)

Odyssey Systems Consultant at MIT Lincoln Laboratories, Lexington, MA Sep 2016 – Feb 2019

Engineer III/QA Lead

Researched and made Proof of Concepts to identify best-in-class quality tools.

Performed engineering tasks, research, studies and analysis that provide engineering, QA, technical, and managerial direction for problem definition, analysis, requirement development, and implementation for complex systems in the engineering disciplines.

Made recommendations and advised on system development, QA improvements, optimization, and support efforts.

Performed risk assessments and analysis employing modelling and simulation techniques.

Designed test automation frameworks and harnesses to test mission critical applications.

Tested mission critical GUI applications using Selenium, Cucumber and Java

Tested mission critical APIs using TestNG, Junit, and Java

Tested RESTful APIs and Java Message Service (JMS) application communication channels.

Designed performance tests using JMeter.

Experienced in Atlassian tools (JIRA, Bitbucket, and Confluence)

Forcepoint, Dallas TX Nov 2014 – Sep 2016

Principal Test Engineer

Developed and documented test cases and test plans for advanced malware protection and cyber security analytics products

Developed test automation frameworks to test advanced malware protection and security analytics products using Java, groovy, maven, and selenium.

Performed manual testing, vulnerability assessment, and penetration testing.

Established and operationalized identified tools and processes to galvanize QA processes for optimum delivery of quality products.

Assisted and supported software engineers with reproducing and debugging identified issues.

Provided hands-on support for security researchers and software engineers with prototypes and test configurations in the lab to isolate and resolve current and anticipated security vulnerabilities.

Designed and coded effective, maintainable JUnit and Selenium tests

Performed cyber security engineering and test.

Performed manual, exploratory, and security testing.

Tested backend databases, APIs, Web services, and frontend GUIs.

United Technologies. Beverly MA Feb 2011 – Sep 2014

Senior Test Automation Engineer

Provided cross-functional test automation lead support for the software, hardware, and firmware engineering groups

Lead software engineering activities that encompassed the responsibilities for automation, system design, specifications, programming and testing.

Implemented hardware test automation as well as software applications and web services testing which include review of manual test cases and adopting them for automation.

Built and executed test harnesses and managed automated test results in a Microsoft Test Foundation Server (TFS) and Microsoft Test Manager (MTM) environment.

Synchronized test artifacts in TFS to MTM and enforced best practices for all users of TFS e.g. project managers, developers, QA engineers, and hardware engineers

Contact this candidate