Principal Systems and Software Test Engineer

Summary

I have extensive experience in testing medical devices and over 11 years n regulated environments where precision and compliance are critical. My work spans both diagnostic tools and surgical devices, and I have been deeply involved in mobile software testing for proprietary medical applications.
Heres a snapshot of my medical device expertise:
Medical Device Domains
Diagnostic Tools: I have tested mobile apps used for medical diagnostics, ensuring they meet stringent performance and usability standards.
Surgical Tools: My testing includes embedded software for surgical devices, focusing on reliability and critical safety and Hazard testing.
Cardiac Monitoring: As Lead QA Engineer at CardioNet, she led software testing for mobile heart monitor devices used in ambulatory cardiac care.
Testing in Regulated Environments
I have worked within FDA-regulated frameworks, applying rigorous testing methodologies to ensure compliance.
I am familiar with Waterfall, Iterative, and Agile models adapted for medical device development, balancing flexibility with documentation and traceability.
Systems Thinking & Risk-Based Testing
I have applied systems thinking to mobile and embedded device testing, uncovering edge cases and boundary conditions that traditional testing might miss.
My approach to risk-based testing is especially relevant in healthcare, where failure can have serious consequences thus I place heavy emphasis on validation testing as well as verifying the product works as designed. .
My blending of technical depth, regulatory awareness, and strategic testing makes me a standout figure in the medical device QA space.

My approach test System Integration Testing approach and has allowed me to create methods to testing any system for any device uncovering inter-dependencies which have often been omitted by testers. I uncover omissions and gaps in the design prior to beginning testing because I study architectures, hardware, firmware and software.

I am a public speaker having conducted workshops in persona and online at various conferences to share my experiences and learn from others. I am also a published author having written for several testing publications on my methods.

Expectations

Opportunity to grow, work/life balance but some overtime is okay. Varied culture, Cross-Functional Collaboration, Cooperation among project team members, True teamwork but with the ability to have honest and constructive feedback. Leadership is willing to listen and to adapt to changing processes for improvement after team discussion.

Employment Preferences

Expected Base Salary

**5,000 USD

Academic Degree

Experience

Skills

• 13Requirements Management
• Development
• System Architecture
• Design Analysis
• Traceability
• Verification
• Validation
• Waterfall
• System Integration Testing
• Gap Analysis
• Risk Analysis
• Mitigation
• FMEA
• Hazard Assessment
• Test Planning
• Execution
• Test Protocols
• IQ
• OQ
• PQ
• Exploratory
• Reliability Testing
• Usability
• Performance Testing
• Clinical Device Testing
• Audit
• Compliance Documentation
• C
• C++
• Python
• SQL
• Code Reviews
• Modifications
• Embedded Software Verification
• Desktop App Analysis
• RTOS
• Jama
• Matrix
• Jira
• Confluence
• Xray
• TestRails
• MasterControl
• Slack
• GitHub Copilot
• PuTTY
• Proprietary Engineering Tools
• DO-178C-E
• AS9001
• 21 CFR 820
• ISO 13485
• ISO 14971
• IEC 62304
• IEC 60601
• GMP
• DHF
• DMR Documentation
• FDA
• IND Submission
• Leadership
• Cross-Functional Collaboration
• Communication
• Problem Solving
• Attention To Detail
• Time Management
• Accountability
• Training Facilitation
• Project Management
• Agile
• Scrum Practice
• Stakeholder Management
• SOP Development
• Training