Senior Systems Verification Engineer - Medical Devices

Intellectt INC; California (MO); On-site; USD 62,000 - 77,000; Full time

Benefits offered by this job

Job summary

Intellectt INC seeks a senior Systems Engineer Verification to lead system-level verification for complex medical-device-related products. Responsibilities include planning, designing, and executing verification across hardware, embedded software, mobile apps, wireless tech, and cloud services.

Required: degree with 5–6 years' experience in system verification or a master's with ≥4 years. Prior regulated development experience and knowledge of IEC 62304/60601 preferred.

Qualifications

• Experience leading system-level verification for complex hardware/software products.
• Familiarity with design controls, configuration management, change management, and quality-system processes.
• Experience with regulated product development; medical device experience is strongly preferred.
• Experience supporting regulatory submissions and audits is desirable.
• Knowledge of cybersecurity and automated system testing for connected products is preferred.

Responsibilities

• Lead system verification planning and execution across new product development and sustaining programs.
• Develop verification strategies, plans, protocols, reports, and traceability matrices.
• Analyze system requirements for completeness, consistency, and testability.
• Define system-level test approaches, acceptance criteria, and verification coverage.
• Maintain bidirectional traceability among needs, requirements, risk controls, and verification evidence.
• Execute verification protocols covering functionality, performance, safety, and reliability.
• Lead defect investigation, root-cause analysis, and verification of corrective actions.
• Verify design mitigations and risk-control measures.
• Support design reviews, verification-readiness reviews, regulatory submissions, audits, design transfer, and sustaining activities.

Skills

Requirements engineering

Traceability

Verification planning

Test design

Defect management

Root-cause analysis

Education

Bachelor's degree in relevant field

Master's degree in relevant field

Tools

DOORS

JIRA

Job description

Intellectt INC seeks a senior Systems Engineer Verification to lead system-level verification for complex medical-device-related products. Responsibilities include planning, designing, and executing verification across hardware, embedded software, mobile apps, wireless tech, and cloud services.

Required: degree with 5–6 years' experience in system verification or a master's with ≥4 years. Prior regulated development experience and knowledge of IEC 62304/60601 preferred.