Position Summary

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.

Key Responsibilities

• 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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.