Senior System Verification Engineer (Medical Device)

Senior System Verification Engineer (Medical Device)

Neko Health

Stockholm, Sweden

We are currently seeking a Senior System Verification Engineer to join our multidisciplinary engineering team. In this role, you will take ownership of system-level verification activities across the product lifecycle, from early concept through industrialization and market release. You will work closely with hardware, firmware, and software teams to ensure our medical device systems meet applicable standards and regulatory requirements, translating compliance needs into practical, testable requirements and robust verification strategies that ensure safety, performance, and regulatory compliance.

Responsibilities

• Partner with design engineers throughout the product development lifecycle to ensure medical device systems are compliant with applicable standards (e.g., IEC 60601 series) and regulatory requirements (e.g., FDA, MDR) from concept through industrialization;
• Translate regulatory requirements and standards into actionable, practical guidance for design decisions, serving as a bridge between regulatory/compliance and engineering teams;
• Influence product requirements early by working with cross-functional teams to ensure requirements are testable, traceable, and specify compliance needs effectively;
• Develop efficient verification methodologies, tools, and workflows, for end-to-end, integration, and regression testing, implementing automation where it optimizes work and increases reliability;
• Coordinate with external test houses for specialized testing (e.g., EMC, electrical safety, environmental.) and manage the interface between internal requirements and external verification activities;
• Ensure continuity of test requirements through design transfer, maintaining product quality, safety, and compliance as products move from development to manufacturing and industrialization;
• Create comprehensive test reports documenting results, defects, and compliance status, and communicate findings to stakeholders;
• Contribute to the creation and maintenance of traceability matrices, ensuring all system requirements are covered by verification activities;
• Provide technical feedback and drive continuous improvement of verification processes and practices.

Requirements

• Bachelor’s or Master’s degree in Engineering or a related technical field;
• 5+ years of experience in system verification and validation within a regulated industry, ideally medical devices;
• Experience working with complex embedded systems (hardware, firmware, software) and performing system-level testing, such as EMC, electrical safety, environmental tests;
• Strong familiarity with IEC 60601 series standards (IEC 60601-1, IEC 60601-1-2, etc.) is highly preferred, with proven ability to translate standard requirements into verification strategies;
• Familiarity with regulatory frameworks such as FDA, MDR, and ISO 14971;
• Hands-on experience developing and executing both manual and automated test methods;
• Excellent collaboration and communication skills, with the ability to work effectively across hardware, firmware, software, quality, regulatory, and external partner teams;
• Good documentation skills and proficiency in English.