Systems Engineer - Verification

Novozen Healthcare LLC; Pleasanton (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Novozen Healthcare LLC in Pleasanton, CA is seeking a senior-level Systems Engineer to lead system verification across hardware, embedded software, mobile apps, wireless technologies, and cloud-enabled services for complex, regulated medical devices. The role requires defining, tracing, and validating requirements to ensure robust verification coverage.

You will plan and execute verification strategies, develop protocols and traceability matrices, analyze requirements, and support regulatory

Qualifications

• Bachelor’s degree with 5–6 years of relevant experience, or a master’s with 4+ years.
• Experience leading system-level verification for complex hardware/software products.
• Strong background in requirements engineering, traceability, verification planning, test design, and root-cause analysis.
• Experience in regulated product development; medical device experience preferred.
• Familiarity with design controls, configuration management, change management, and quality-system processes.
• Experience with DOORS, JIRA or similar tools.
• Familiarity with IEC 62304, IEC 60601, ISO 14971 or similar standards.
• Experience with connected products involving embedded firmware, mobile apps, Bluetooth, Wi-Fi, cloud services, cybersecurity, or automated system testing.

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.

Skills

System verification

Requirements engineering

Traceability

Verification planning

Test design

Root-cause analysis

Regulatory submissions

Education

Bachelor’s degree

Master’s degree

Tools

DOORS

JIRA

Job description

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.

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.

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 checks may be conducted in accordance with applicable law.

Work Authorization:

Applicants must be authorized to work in the United States.