System Verification Engineer

The Systems Engineer will lead system-level verification activities for complex, regulated medical devices. This role is responsible for ensuring requirements are defined, traceable, testable, and verified across hardware, software, mobile applications, wireless technologies, and cloud-connected services. The engineer will develop verification strategies, execute testing activities, and ensure compliance with quality and regulatory requirements throughout the product lifecycle.

Lead system verification activities from requirements development through design transfer and sustaining support.

Develop verification strategies, plans, protocols, reports, and traceability matrices.

Review requirements for completeness, consistency, and testability.

Define system-level test approaches, acceptance criteria, and verification coverage.

Maintain traceability between user needs, system requirements, risk controls, and verification evidence.

Design and execute verification testing to confirm functional, performance, safety, and reliability requirements.

Investigate defects, perform root-cause analysis, and verify corrective actions.

Support risk management activities and verification of risk controls.

Collaborate with Systems, Software, Hardware, Quality, Clinical, Regulatory, and Test Engineering teams.

Assess verification impacts of design changes and support design reviews, audits, and regulatory submissions.

Drive continuous improvement of verification processes, tools, and methodologies.

Communicate verification status, technical findings, and risks to project teams and leadership.

Bachelor's degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Software Engineering, Computer Science, or related field with 5+ years of experience, or Master's degree with 4+ years of experience.

Experience leading system-level verification for complex hardware-software products.

Strong knowledge of requirements management, traceability, verification methodologies, and system testing.

Experience developing verification plans, protocols, test methods, and reports.

Background in regulated industries such as medical devices, aerospace, automotive, or defense.

Experience with defect management, root-cause analysis, risk management, and quality system processes.

Knowledge of design controls, configuration management, and change management.

Strong communication, analytical, and problem-solving skills.

Ability to independently drive verification activities in cross-functional environments.

Experience supporting Class II and/or Class III medical device regulatory submissions.

Medical device experience, especially connected or software-enabled products.

Familiarity with IEC 62304, IEC 60601, ISO 14971, or related standards.

Experience developing automated verification solutions and test frameworks.

Experience verifying systems involving embedded firmware, mobile applications, Bluetooth, Wi-Fi, cloud services, and cybersecurity features.

Experience with DOORS, JIRA, or similar requirements and defect management tools.

Experience supporting validation, design transfer, and post-market activities.

Strong systems-thinking approach, organizational skills, and attention to detail.