Systems Engineer – Verification

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

Systems Engineer Verification

Location: Bay Area, CA

Duration: 1-year, possible extensions

Rate: $45/hr - $56/hr on W2

Overview

Seeking a senior-level Systems Engineer to lead and execute system-level verification activities for complex, regulated medical devices. The engineer will ensure requirements are well-defined, traceable, testable, and objectively verified across hardware, embedded software, mobile applications, wireless technologies, and cloud-connected services.

Responsibilities

• Lead system verification planning and execution across new product development and sustaining programs.
• Develop verification strategies, plans, protocols, reports, test methodologies, 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 stakeholder needs, system requirements, risk controls, and verification evidence.
• Execute system-level 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.

Target Background

• Bachelor's degree with approximately 5 6 years of relevant experience, or a master's degree with at least 4 years of relevant experience.
• Experience leading system-level verification for complex hardware/software products.
• Strong background in requirements engineering, traceability, verification planning, test design, defect management, and root-cause analysis.
• Experience in regulated product development; medical device experience is strongly preferred, although aerospace, automotive, defense, or similar industries may be considered.
• Familiarity with design controls, configuration management, change management, and quality-system processes.
• Experience supporting Class II and/or Class III medical device submissions is highly desirable.
• Experience with DOORS, JIRA, or similar requirements and defect-management tools.
• Familiarity with IEC 62304, IEC 60601, ISO 14971, or comparable standards is preferred.
• Experience with connected products involving embedded firmware, mobile applications, Bluetooth, Wi-Fi, cloud services, cybersecurity, or automated system testing is preferred.

Benefits:

This a contract position does not include employer-provided benefits.

Equal Opportunity Employer:

We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to

race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Background Check:

Background checks may be conducted in accordance with applicable law.

Work Authorization:

Applicants must be authorized to work in the United States.