Systems Engineer

Intellectt INC; California (MO); On-site; USD 62,000 - 69,000; Full time

Job summary

Intellectt INC is seeking a Systems Engineer Verification to support system-level verification of complex, regulated medical devices, including hardware, embedded software, mobile apps, wireless connectivity, and cloud services.

The role requires strong V&V experience, familiar with IEC 62304/60601/ISO 14971, and collaboration across design reviews, regulatory submissions, and sustaining activities. 1-year contract in CA with pay of $45-$50/hr on W2 (DOE).

Qualifications

• Bachelor's degree with approximately 5–6 years of relevant experience or Master's with 4+ years.
• Strong system-level verification/V&V experience with complex hardware/software products.
• Experience with requirements engineering, traceability, test design, and defect management.
• Regulated product-development experience; medical device experience strongly preferred.
• Knowledge of Design Controls, risk management, configuration/change management, and quality systems.
• Experience with DOORS, JIRA, or similar tools.
• Familiarity with IEC 62304, IEC 60601, and ISO 14971.
• Class II/Class III medical device experience is highly desirable.
• Experience with embedded firmware, Bluetooth/Wi-Fi, mobile applications, cloud services, or automated system testing is a plus.
• Must be able to provide recent client references.

Responsibilities

• Lead system-level verification planning and execution.
• Develop verification plans, protocols, reports, test methodologies, and traceability matrices.
• Review system requirements for completeness, consistency, and testability.
• Define test approaches, acceptance criteria, and verification coverage.
• Maintain traceability between requirements, risk controls, and verification evidence.
• Execute functional, performance, safety, and reliability testing.
• Support defect investigation, root-cause analysis, and corrective-action verification.
• Participate in design reviews, regulatory submissions, design transfer, and sustaining activities.

Skills

System verification

Requirements engineering

Traceability

Defect management

Medical device experience

Education

Bachelor's degree in engineering

Master's degree in engineering

Tools

DOORS

JIRA

Job description

We're Hiring: Systems Engineer Verification

Location: CA
Duration: 1 Year Contract with Possible Extensions
Pay Rate: $45 $50/hr on W2 (DOE)

Job Summary

We are seeking an experienced Systems Engineer Verification to support system-level verification of complex, regulated medical devices involving hardware, embedded software, mobile applications, wireless connectivity, and cloud-connected technologies.

Key Responsibilities:

• Lead system-level verification planning and execution
• Develop verification plans, protocols, reports, test methodologies, and traceability matrices
• Review system requirements for completeness, consistency, and testability
• Define test approaches, acceptance criteria, and verification coverage
• Maintain traceability between requirements, risk controls, and verification evidence
• Execute functional, performance, safety, and reliability testing
• Support defect investigation, root-cause analysis, and corrective-action verification
• Participate in design reviews, regulatory submissions, design transfer, and sustaining activities

Key Requirements:

• Bachelor's degree with approximately 5 6 years of relevant experience OR Master's degree with 4+ years of relevant experience
• Strong system-level verification/V&V experience with complex hardware/software products
• Experience with requirements engineering, traceability, test design, and defect management
• Regulated product-development experience; medical device experience strongly preferred
• Knowledge of Design Controls, risk management, configuration/change management, and quality systems
• Experience with DOORS, JIRA, or similar tools
• Familiarity with IEC 62304, IEC 60601, and ISO 14971
• Class II/Class III medical device experience is highly desirable
• Experience with embedded firmware, Bluetooth/Wi-Fi, mobile applications, cloud services, or automated system testing is a plus
• Must be able to provide recent client references