SYSTEMS ENGINEER

Tekhawks LLC; Pleasanton (CA); On-site; USD 140,000 - 180,000; Full time

Job summary

Tekhawks LLC in the Bay Area is seeking a senior Systems Engineer to drive system-level verification for complex medical devices, spanning hardware, embedded software, mobile apps, wireless tech, and cloud services. You will establish requirements traceability, design verification plans, risk-based testing, and documentation to support regulatory submissions and product realization.

Applicants should have 5–6 years in system verification roles or a 4-year master's with similar experience, and

Qualifications

• 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 preferred.
• Familiarity with design controls, configuration management, change management, and quality-system processes.
• Experience supporting Class II and/or Class III medical device submissions is desirable.

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

System verification

Requirements engineering

Traceability

Test design

Root-cause analysis

Regulated development

Design controls

Quality systems

Medical device experience

Education

Bachelor’s degree

Master’s degree

Tools

DOORS

JIRA

Job description

Job Description

Job Description

** Title: SYSTEMS ENGINEER – VERIFICATION**

** Location: Bay Area, CA**
** Duration: 1-year, possible extensions**

** 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.