Senior System Verification Engineer, Medical Devices

The role

You will own the system verification strategy for instruments from concept through market release. You will work with hardware, firmware, software, and manufacturing teams to ensure requirements are testable, traceable, and compliant.

What you will do

• Own the system-level verification strategy for instruments from concept through industrialization and market release
• Develop, execute, and sign off on verification methods, protocols, and workflows
• Document results, defects, and compliance status for regulatory submissions
• Shape product requirements to be testable and traceable
• Maintain traceability matrices
• Contribute to risk identification, assessment, and risk control verification
• Apply a risk-based approach to verification strategy
• Coordinate specialized testing with external test houses
• Work with manufacturing to carry test requirements through design transfer
• Support controlled device updates with verification and risk-assessment evidence

Required qualifications

• 5+ years in system verification of medical devices, including devices governed by the IEC 60601-1 series
• Proven work experience with testing and verification of complex embedded systems
• Track record designing verification test methods from scratch
• Experience contributing to risk assessment under ISO 14971
• Comfortable working across hardware, firmware, software, quality, regulatory, manufacturing, and external partner teams
• Bachelor's or Master's degree in engineering or a related technical field
• Professional English

Nice to have

• Familiarity with regulatory frameworks such as FDA and MDR
• Experience developing automated tests
• Experience designing test rigs for reliable and repeatable testing

About the company

Neko is redefining what prevention means by making data-driven, preventative care accessible through proprietary technology and direct clinical care.