Senior Systems Verification Engineer - Medical Devices

Compunnel, Inc. (old); Pleasanton (CA); Hybrid; USD 130,000 - 180,000; Full time

Job summary

Compunnel, Inc. is seeking a senior Systems Engineer – Verification Engineer to lead system-level verification for complex, regulated medical devices.

The role focuses on defining, tracing, testing, and verifying requirements across hardware, software, mobile apps, wireless tech, and cloud services. The ideal candidate has strong systems engineering and verification expertise, with experience developing verification strategies, methodologies, and root-cause analysis.

Qualifications

• Bachelor’s degree in a technical field with 5–6 years of relevant experience, or Master’s with 4+ years.
• Experience leading system-level verification efforts for complex hardware-software products.
• Strong knowledge of requirements engineering, traceability, and verification methodologies.
• Experience in regulated product development environments (medical devices, aerospace, automotive, etc.).
• Familiarity with design controls, configuration and change management, and quality systems.

Responsibilities

• Lead system verification planning and execution across the product lifecycle.
• Develop and maintain verification strategies, plans, and traceability matrices.
• Analyze system requirements for completeness, consistency, and testability.
• Define system-level test approaches, acceptance criteria, and verification coverage.
• Maintain bidirectional traceability between needs, requirements, risk controls, and evidence.
• Design, develop, and execute verification protocols to meet functional, performance, and safety requirements.
• Lead defect investigation and root-cause analysis; verify corrective actions.
• Support risk management activities with verified design mitigations.
• Collaborate with cross-functional teams to identify gaps and improve quality.
• Review design changes and assess verification impacts; support reviews and audits.
• Drive continuous improvement of verification processes and tools.
• Communicate status, risks, and findings to teams and leadership.

Skills

Systems engineering

Verification

Requirements engineering

Traceability

Medical device experience

Root-cause analysis

Risk management

Cross-functional collaboration

Regulatory submissions

Documentation

Education

Bachelor’s degree in Systems Engineering

Master’s degree in related technical field

Tools

DOORS

JIRA

Job description

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.