Gloria Yong
- Role
- Staff Software Systems Engineer at Abbott
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Gloria Yong
R&D systems engineering leader in medical devices and information systems. Utilize…
Experience
Staff Software Systems Engineer
Aug 2019 — Present
Managed a team of 2-6 engineers assigned to new product development, sustaining and remediation projects with responsibilities in software planning, software requirements analysis and definition, software traceability, software risk analysis, software trace matrices, unit verification reports and non-product software validation for FDA class heart failure medical devices. Individually authored and/or oversaw completion of these deliverables for 8 regulatory submissions within a time frame of less than 2.5 years. Prioritized team resources to meet company objectives for two different product lines. Responsible for hiring, onboarding, coaching, training, and developing the software systems team. Enabled the launch of two iPad applications, multiple iPad application software changes, a major software update to a back-end web application, a software update to support a new cellular modem on a legacy product, and a software update for the controller of a heart pump as an individual contributor and core team lead. As a core team lead, performed careful planning, identified dependencies, risk management, communication to stakeholders, task management, and follow up to release software. Led technical reviews of software requirements, assessed software changes for requirements impact and provided input on test strategy. Reviewed and approved V&V Plans and Technical Design Reviews. Performed assessments of non-product software and performed non-product software validation. Supported audits, provided FDA and EU MDR submission responses as needed, created and updated 62304 checklists, and assisted with CAPAs.
Skills
- Software Documentation
- Software Development
- Management
- Quality Assurance
- Human Factors Engineering
- Cross-Functional Team Leadership
- Medical Devices
- Integration
- Risk Management
- Analysis
- Program Management
- Systems Analysis
- Systems Engineering
- Leadership
- Sdlc
- Testing
- Databases
- Requirements Management
- Troubleshooting
- Project Management
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