Don Hyatt

ad1hty@r.postjobfree.com 919-***-**** https://www.linkedin.com/in/don-hyatt/ Cary, NC US Citizen

Senior Quality Engineer

Extensive experience in Quality Engineering for Medical Devices adhering to IEC 62304 with IBM Watson Health/Merative, including writing test cases, verifying test results, applying requisite SOPs, and managing related Quality Management Systems. Very adept at managing cross-organizational and international collaborative software development.

Experienced in all phases of the software development process on multiple platforms including Windows, AIX, z / OS, and Linux. Extensive experience in rapid, iterative development on multiple platforms simultaneously. Ongoing project leadership roles including all aspects of resource planning and budgeting. Excels at client-facing interactions including conference planning and key speaker roles.

TECHNICAL SKILLS

IEC 62304 • 21 CFR Part 820 while adhering to a QMS governed by ISO 13485 • Verification and Validation (V&V) • Good Laboratory Practice (GLP) • Medical Devices • Requirements Gathering • Quality Control • Quality Assurance • C & Python

KEY SKILLS

Windows Server Security

Network Security

Linux Server Security

Virtualization

Windows Domain Architecture

Distributed Team Management

Windows Solution Architecture and Design

Distributed Solution Architecture

Linux Solution Architecture and Design

Release Manager

Product Manager

Development Manager

Budgeting

Personnel Planning

Long-Term Strategy

Architecture Windows, z / OS, AIX, Linux

Design on Windows, z / OS, AIX, Linux

REST APIs, C / C ++, Java, and others

Experience developing dynamic web content by

using Flash, ASP, DHTML, JavaScript, and XML

Java and multiple scripting languages (PHP, Perl, REXX, LotusScript, JavaScript)

Experience in Web 2.0 development, using AJAX and Ruby

Broad experience in REST APIs, Python C / C++,

Eclipse plug-in architecture and development

Experience with build and installation on Windows, AIX, and Linux

OpenText Content

Platform Suite Administration

Merative L.P. (IBM Watson Health) 2020 – 8/31/2023

Merative L.P., formerly IBM Watson Health, is an American medical technology company that provides products and services that help clients facilitate medical research, clinical research, real world evidence, and healthcare services, through the use of artificial intelligence, data analytics, cloud computing, and other advanced information technology. Merative is owned by private equity firm Francisco Partners. Merative serves 9 of the top 10 US hospitals, 7 of the top 9 US health plans, and all 20 of the top 20 life sciences companies. Its six core products include: Health Insights - MarketScan - Clinical Development - Social Program Management and Phytel – Micromedex - and Merge Imaging.

Senior Quality Engineer, 2020 - 2023

Supported Merge Healthcare Imaging (Merge PACS) and Hemo & Cardio products.

Exclusively performed QA for products developed under IEC 62304 and 21 CFR Part 820 while adhering to a QMS governed by ISO 13485.

In July 2023, we successfully completed ‘without any findings’ a full EU MDR audit covering the QMS & Imaging products. The audit was required to show adherence to EU 2023/607 adopted earlier in the year. Worked with internal team to support both internal and external audits.

Assisted with CAPA analysis and remediation.

Provided support for QMS, including controlling, and reviewing documentation and ensuring required elements were correct. Worked with overall team to promote QMS compliance.

Collaborated to ensure QMS maintained all applicable regulations in USA, Japan, and Brazil.

Reviewed and approved CSV records, and administered WHU and Jira tools as required.

IBM WATSON HEALTH

Senior OpenText System Administrator, 2017 - 2020

I spent 50% performing Quality work, and 50% in administration.

Provided ongoing user support, security upgrades, vulnerability and penetration scans, and solution workflow enhancements for 4,000 users.

Created front-end portal and workflows (prior to OpenText TeamSite acquisition), maintaining account privacy across tenants.

Created WebReports, requiring both OScript and SQL queries as requested by clients.

Handled all aspects of server and associated network security for quality document management system and associated learning development system.

Delivered REST APIs and associated Python-based tooling to support user management.

Expanded and delivered document workflows in support of customer requirements.

Delivered VMware virtualized environment on cloud to reduce hosting costs over comparable bare metal servers.

IBM

GTS Life Science - Program Manager for Tools & Technology, 2014 - 2017

Architected, built, and co-validated all aspects of solution and user management for quality document management system based on OpenText Content Platform Suite, OpenText Learn Flex, and IBM Cloud Architecture.

Developed requirements for FDA-compliant hardware infrastructure.

Managed and enforced network and software security. Performed regular vulnerability tests, penetration tests, and threat assessments.

Supported 4,000 users and developed, validated, and delivered custom workflows. Developed OScript, Python and SQL tools for user management.

IBM

2nd Software Development Manager, 2011 - 2014

Acted as second-line development manager for SCORE (Solution for Compliance in a Regulated Environment).

Managed team of experienced software engineers.

Performed release manager role for product rollouts.

Presented new offerings at trade shows and customer locations.

Guided product direction based on new FDA and EMA requirements as well as large pharmaceutical company client input.

IBM

Senior Software Engineering Manager, 1997 - 2011

Managed team of software engineers covering entire product lifecycle, including requirements gathering, development, support, and eventual product retirement.

Designed and wrote graphics sub-systems for book manager products on DOS, Windows, OS / 2, VM, AIX, and Linux. Provided design guidance for graphics sub-system on MVS.

Wrote graphics system for book-server and library-server web graphics implementations and developed design in response to provided requirements.

Led Agile development team to build and test new product offerings in electronic publishing space.

Coded and tested image compression and manipulation components, using C, C++, Java, and .NET.

Coded and tested end user interfaces by using MS Visual Studio and Studio.NET for Windows and Java for Linux.

Contact this candidate