Job Description

Job Title: Systems Engineer Verification (Medical device)

Location: Bay Area, CA

Duration: 12 Months

Employment Type: W2 Contract

Rate: $45 - $55/hr W2

Experience: 5 6 Years

Position Overview:

We are seeking a Senior Systems Engineer Verification to lead and execute system-level verification activities for complex, regulated medical device products.

The ideal candidate will have strong experience with system-level verification, requirements engineering, verification planning, test design, traceability, defect management, and root-cause analysis. The engineer will work across hardware, embedded software, mobile applications, wireless technologies, and cloud-connected services throughout the medical device product development lifecycle.

Key Responsibilities:

• Lead system verification activities for new and existing products
• Create verification plans, protocols, reports, test methods, and traceability documents
• Review system requirements to ensure they are clear, complete, and testable
• Develop system-level test plans, acceptance criteria, and verification coverage
• Maintain traceability between requirements, risks, controls, and test results
• Perform system testing for functionality, performance, safety, and reliability
• Investigate test failures, defects, and root causes
• Verify corrective actions and risk-control measures
• Support design reviews, audits, regulatory submissions, and design transfer
• Work closely with R&D, Quality, Regulatory, Software, and Hardware teams
• Ensure verification activities follow quality procedures and industry standards
• Support medical device design controls and risk management

Required / Preferred Qualifications:

• Bachelor's degree with 5 6 years of relevant experience, or Master's degree with 4+ years
• Strong experience in system-level verification of hardware/software products
• Experience with requirements engineering, traceability, verification planning, and test execution
• Experience creating verification plans, protocols, reports, and test methods
• Experience with defect investigation, troubleshooting, and root-cause analysis
• Experience in a regulated industry; medical device experience strongly preferred
• Aerospace, automotive, or defense experience may also be considered
• Knowledge of design controls, configuration management, and change management
• Class II/III medical device experience is a plus
• Knowledge of IEC 62304, IEC 60601, or ISO 14971 is preferred
• Experience with embedded software, mobile apps, Bluetooth/Wi-Fi, cloud, cybersecurity, or connected products is a plus

Job Tags

Similar Jobs