Senior System Verification Engineer

LivaNova

Mirandola, Italy

Who are we looking for:

Are you passionate about testing complex systems and ensuring that innovative medical devices meet the highest standards of safety, performance, and regulatory compliance?

We are looking for a Senior System Verification Engineer to join our R&D team and play a key role in the verification of integrated hardware and software medical devices throughout the product development lifecycle.

In this role, you will lead system-level verification activities, working closely with Systems Engineering, Software, Hardware, and Quality teams to ensure product requirements are fully verified and documented according to international standards and regulatory expectations.

Your new role:

Lead the definition and execution of system verification strategies for complex medical devices;
Translate system requirements into comprehensive verification plans, protocols, test cases, and traceability matrices;
Execute and coordinate system-level testing activities, including functional, performance, usability, and safety verification;
Collaborate with Systems Engineering, Software, Hardware, and Quality teams to ensure complete requirements coverage;
Analyze test results using statistical methods and prepare technical reports to support product development decisions;
Investigate verification failures, identify root causes, and support corrective actions;
Manage verification activities, including planning, scheduling, resource allocation, and progress tracking;
Ensure verification documentation is audit-ready and compliant with applicable regulatory requirements;
Support risk management activities and contribute to product safety assessments;
Contribute to regulatory submissions and support internal and external audits;
Mentor junior engineers and promote best practices in system verification and validation;
Drive continuous improvement initiatives related to verification processes, methodologies, and tools.

How you'll make an impact:

Ensure that medical devices are thoroughly verified and meet customer, quality, and regulatory requirements;
Contribute to the development of safe, reliable, and high-performing healthcare technologies;
Support successful product launches through robust verification planning and execution;
Strengthen collaboration between engineering disciplines and quality functions;
Improve product quality by identifying issues early in the development lifecycle;
Enhance verification effectiveness through process improvements and technical leadership;
Help maintain compliance with global medical device standards and regulations.

About you:

Bachelor's or Master's degree in Biomedical Engineering, Electronic Engineering, Systems Engineering, or a related technical field;
3+ years of experience in Verification & Validation (V&V), System Verification, or Testing within the Medical Device industry or other highly regulated sectors;
Proven experience verifying complex systems involving both hardware and software components;
Strong understanding of requirements management and traceability principles;
Knowledge of medical device standards and regulations, including:
- IEC 60601;
- ISO 13485;
- ISO 14971;
- FDA regulations;
- European MDR.
Experience with requirements and defect management tools such as DOORS, Jira, or similar platforms;
Familiarity with statistical analysis tools such as Minitab, Excel, or equivalent tools;
Basic programming or scripting experience with Python, MATLAB, or similar languages;
Understanding of embedded systems, hardware-software integration, and software validation principles;
Strong analytical and problem-solving capabilities;
Excellent communication and technical documentation skills;
Ability to work effectively within multidisciplinary and cross-functional teams;
Fluent English, both written and spoken.