Job Summary:
We are seeking a senior-level Systems Engineer - Verification Engineer to lead and execute system-level verification activities for complex, regulated medical devices. The role focuses on ensuring system requirements are well-defined, traceable, testable, and objectively verified across hardware, software, mobile applications, wireless technologies, and cloud-connected services. The ideal candidate will have strong systems engineering and verification expertise, experience developing verification strategies and methodologies, and strong root-cause analysis skills.

Key Responsibilities:
• Lead system verification planning and execution across the full product lifecycle, from requirements development through design transfer and sustaining activities.
• Develop and maintain system verification strategies, verification plans, protocols, reports, and traceability matrices.
• Analyze system requirements for completeness, consistency, and testability, ensuring clear verification methods are defined.
• Define system-level test approaches, acceptance criteria, and verification coverage for complex hardware-software systems.
• Establish and maintain bidirectional traceability between stakeholder needs, system requirements, risk controls, and verification evidence.
• Design, develop, and execute system-level verification protocols to confirm compliance with functional, performance, safety, and reliability requirements.
• Lead system defect investigation, root-cause analysis, and verification of corrective actions.
• Support risk management activities by ensuring design mitigations are appropriately verified and documented.
• Collaborate with cross-functional engineering teams to identify verification gaps, resolve technical issues, and improve product quality.
• Review design changes and assess verification impacts throughout product development and sustaining efforts.
• Support verification readiness reviews, design reviews, regulatory submissions, and audit activities.
• Drive continuous improvement of verification processes, methodologies, tools, and best practices.
• Communicate verification status, risks, technical findings, and recommendations to project teams and leadership.

Required Qualifications:
• Bachelor's degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Software Engineering, Computer Science, or a related technical field with 5-6 years of relevant experience, or a Master's degree in a related technical field with a minimum of 4 years of relevant experience.
• Demonstrated experience leading system-level verification efforts for complex hardware-software products.
• Strong understanding of requirements engineering, requirements traceability, and verification methodologies.
• Experience developing verification plans, protocols, test methods, and verification reports.
• Experience working in regulated product development environments, including medical devices, aerospace, automotive, defense, or similar industries.
• Strong knowledge of system test design, defect management, root-cause analysis, and issue resolution.
• Experience supporting risk management activities and verification of risk control measures.
• Familiarity with design controls, configuration management, change management, and quality system processes.
• Excellent written and verbal communication skills with the ability to communicate complex technical information to diverse stakeholders.
• Proven ability to independently drive verification activities in cross-functional environments.
• Experience supporting regulatory submissions for Class II and/or Class III medical devices.

Preferred Qualifications:
• Medical device experience, particularly with connected or software-enabled medical devices.
• Familiarity with IEC 62304, IEC 60601, ISO 14971, or similar standards.
• Experience developing automated system-level verification solutions and test frameworks.
• Experience verifying systems involving embedded firmware, mobile applications, Bluetooth, Wi-Fi, cloud services, and cybersecurity features.
• Experience with requirements, configuration, and defect management tools such as DOORS and JIRA.
• Experience supporting verification activities through validation, design transfer, and post-market sustaining efforts.
• Strong systems-thinking mindset with the ability to balance technical depth and broader system impacts.
• Strong organizational skills, ability to prioritize work, and consistent attention to detail.