SYSTEMS ENGINEER – VERIFICATION

Black Diamond Networks; Pleasanton (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Black Diamond Networks seeks a senior-level Systems Engineer to lead system-level verification for complex medical devices, ensuring requirements are well-defined, traceable, and testable across hardware, embedded software, mobile apps, wireless tech, and cloud services.

Responsibilities include planning verification activities, developing strategies, analyzing requirements, and maintaining traceability across all development stages. Strong regulatory experience preferred.

Qualifications

• Bachelor’s degree with 5–6 years of relevant experience or a Master’s with at least 4 years.
• 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 with regulated medical device development; DOORS/JIRA experience preferred.

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 needs, 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

Requirements engineering

Traceability

Verification planning

Test design

Defect management

Root-cause analysis

Regulated medical devices

Education

Bachelor's degree in engineering or related field

Master's degree in engineering or related field

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.

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.