Kevin Best
Principal Software Quality Engineer | Embedded & Medical Device Systems | Verification, Automation, IEC 62304, ISO 13485
- Role
- Senior Software Quality Engineer at HiArc
- Location
- Haverhill, MA, US
- LinkedIn followers
- 500 followers
About Kevin Best
I am a Principal Embedded Software Test Engineer with over 10 years of experience leading verification, validation, and test automation for complex, safety-critical embedded systems, including regulated medical device and diagnostic platforms. I specialize in ensuring embedded software reliability, compliance, and system-level performance in high-risk environments where quality and patient safety are paramount.I work across the full software lifecycle, from defining requirements and ensuring traceability to system integration, release readiness, and post-market support. I lead and execute IEC 62304–aligned verification strategies, combining risk-based testing with disciplined documentation to meet regulatory and engineering expectations without slowing innovation.I have extensive hands-on experience developing and executing both manual and automated test plans for embedded systems. I collaborate closely with embedded software, electrical, systems, and hardware engineering teams to validate tightly integrated platforms. I design and enhance Python-based automation frameworks, CI/CD validation pipelines, and custom test tools that reduce manual regression effort while improving defect detection and coverage.I am highly skilled in system-level troubleshooting, applying software diagnostics and hardware analysis to identify root causes, drive corrective actions, and prevent defect recurrence. I also design test fixtures, develop automation tooling, and validate real-time and safety-critical systems where reliability is non-negotiable.In regulated environments, I strengthen quality management systems, support CAPA and root-cause initiatives, and improve audit readiness through clear traceability and rigorous verification practices. I mentor engineers in embedded testing, automation methods, and quality-first thinking, helping teams scale while maintaining high standards.My technical toolkit includes Python automation, Linux and Windows scripting, embedded systems testing, hardware–software integration, CI/CD validation, and tools such as Jira, Jenkins, and requirements management platforms.I am motivated by contributing to life-saving medical technologies, particularly in cardiovascular and interventional domains, where robust verification directly impacts patient outcomes. I am seeking Principal-level embedded software test and verification roles within medical device and safety-critical R&D organizations.
Experience
Senior Software Quality Engineer
Jul 2025 — Present
Education
Brandeis University
Graduate Certificate, Software Engineering
2000 — 2002
University at Albany
BA, English
1983 — 1987
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