Job Summary

• Bachelor’s degree in Computer Science, Software Engineering, Electrical Engineering, Computer Engineering, Biomedical Engineering, or a related technical discipline.
• At least 10 years of software test engineering, quality engineering, or software verification and validation experience, including demonstrated technical leadership.
• Proven experience defining verification strategy and quality direction for complex embedded, connected, safety-critical, medical-device, or similarly regulated software products.
• Experience leading risk-based verification planning across unit, integration, system, regression, performance, simulator-based, and end-to-end test levels.
• Strong capability to evaluate requirements for completeness, clarity, testability, risk, and acceptance criteria; ability to influence requirements and verification approach before implementation begins.
• Demonstrated ownership of end-to-end traceability across requirements, risk controls, test plans/protocols/cases, defects, test results, release evidence, and Design History File records.
• Experience leading the design or evolution of automated test frameworks, CI/CD verification stages, test environments, simulator infrastructure, and quality metrics.
• Advanced hands-on proficiency in Python, C/C++, Bash, or comparable languages for test automation, tooling, test-environment development, diagnostic analysis, and test-data analysis.
• Demonstrated leadership in defect investigation, root-cause analysis, corrective-action verification, release-readiness decisions, and systemic quality improvement.
• Experience leading FMEA and hazard-analysis contributions, risk-control verification, design reviews, quality decisions, and cross-functional technical discussions.
• Strong experience using Jama and Jira, or equivalent ALM/traceability and issue-management platforms, to maintain complete, reviewable, audit-ready verification evidence.
• Proven cross-functional influence with Software Development, Systems Engineering, Quality, Product Security, Regulatory, Product Management, and program stakeholders.
• Demonstrated mentoring, coaching, or technical leadership of test/verification engineers.
• Strong communication and decision-making ability, including clear presentation of quality risks, test coverage, residual risk, readiness status, and recommended actions to technical and non-technical stakeholders.

Key Responsibilities

• Bachelor’s degree in Computer Science, Software Engineering, Electrical Engineering, Computer Engineering, Biomedical Engineering, or a related technical discipline.
• At least 10 years of software test engineering, quality engineering, or software verification and validation experience, including demonstrated technical leadership.
• Proven experience defining verification strategy and quality direction for complex embedded, connected, safety-critical, medical-device, or similarly regulated software products.
• Experience leading risk-based verification planning across unit, integration, system, regression, performance, simulator-based, and end-to-end test levels.
• Strong capability to evaluate requirements for completeness, clarity, testability, risk, and acceptance criteria; ability to influence requirements and verification approach before implementation begins.
• Demonstrated ownership of end-to-end traceability across requirements, risk controls, test plans/protocols/cases, defects, test results, release evidence, and Design History File records.
• Experience leading the design or evolution of automated test frameworks, CI/CD verification stages, test environments, simulator infrastructure, and quality metrics.
• Advanced hands-on proficiency in Python, C/C++, Bash, or comparable languages for test automation, tooling, test-environment development, diagnostic analysis, and test-data analysis.
• Demonstrated leadership in defect investigation, root-cause analysis, corrective-action verification, release-readiness decisions, and systemic quality improvement.
• Experience leading FMEA and hazard-analysis contributions, risk-control verification, design reviews, quality decisions, and cross-functional technical discussions.
• Strong experience using Jama and Jira, or equivalent ALM/traceability and issue-management platforms, to maintain complete, reviewable, audit-ready verification evidence.
• Proven cross-functional influence with Software Development, Systems Engineering, Quality, Product Security, Regulatory, Product Management, and program stakeholders.
• Demonstrated mentoring, coaching, or technical leadership of test/verification engineers.
• Strong communication and decision-making ability, including clear presentation of quality risks, test coverage, residual risk, readiness status, and recommended actions to technical and non-technical stakeholders.

Skill Requirements

• Proven experience defining verification strategy and quality direction for complex embedded, connected, safety-critical, medical-device, or similarly regulated software products.
• Experience leading risk-based verification planning across unit, integration, system, regression, performance, simulator-based, and end-to-end test levels.
• Strong capability to evaluate requirements for completeness, clarity, testability, risk, and acceptance criteria; ability to influence requirements and verification approach before implementation begins.
• Demonstrated ownership of end-to-end traceability across requirements, risk controls, test plans/protocols/cases, defects, test results, release evidence, and Design History File records.
• Experience leading the design or evolution of automated test frameworks, CI/CD verification stages, test environments, simulator infrastructure, and quality metrics.
• Advanced hands-on proficiency in Python, C/C++, Bash, or comparable languages for test automation, tooling, test-environment development, diagnostic analysis, and test-data analysis.
• Demonstrated leadership in defect investigation, root-cause analysis, corrective-action verification, release-readiness decisions, and systemic quality improvement.
• Experience leading FMEA and hazard-analysis contributions, risk-control verification, design reviews, quality decisions, and cross-functional technical discussions.
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Other Requirements

Good to Have

• Direct Class II or Class III medical-device experience and practical application of IEC 62304, ISO 14971, FDA Design Controls, validation principles, FDA cybersecurity expectations, and Design History File processes.
• Experience leading audit, inspection, regulatory-submission support, investigation response, or verification-evidence review activities.
• Strong technical depth in Embedded Linux, device/board integration, networked systems, cloud-connected devices, and complex system test strategy.
• Leadership of software-in-the-loop, hardware-in-the-loop, simulation-based test, virtual-device, hardware-test-infrastructure, or scalable lab/test-environment design.
• Experience verifying CAN, CAN-FD, CANopen, Ethernet, UART, SPI, I2C, and similar embedded communication protocols.
• Experience establishing performance, reliability, endurance, fault-injection, security, negative, recovery, and rollback testing strategies.
• Experience with cybersecurity verification, SBOM/vulnerability validation, secure-boot verification, signed-artifact verification, secure OTA/update testing, and threat/risk-based test planning.
• Experience establishing verification standards, quality metrics, automation roadmaps, reusable test frameworks, and continuous-improvement programs.
• Experience testing embedded HMI/user workflows, usability-related requirements, or human-factors design inputs.

Nice to Have

• ISTQB Expert Level, CSQE, ASQ certification, or comparable quality, verification, regulatory, or test-automation credentials.
• Direct Jama administration/configuration, advanced traceability dashboards, evidence-report automation, or metrics-governance experience.
• Direct ownership of GitLab CI/CD test-platform configuration; equivalent enterprise CI/CD test-platform experience is transferable.
• Experience leading external test partners, suppliers, contract manufacturers, or geographically distributed verification teams.
• Experience supporting usability engineering, human-factors studies, clinical workflow validation, or complex medical-device HMI verification.
• Publications, patents, industry presentations, or recognized technical leadership in quality engineering, automated verification, or regulated embedded systems.
• Experience verifying AI/ML-enabled features, edge AI, adaptive algorithms, data quality, model-version controls, or AI-related risk controls in a regulated environment.