Systems Validation Engineer
Pubblicato il 10-09-2026 - Amaris Consulting in Modena
Join our team and start a new adventure in an international and dynamic environment, where you will be able to fulfil your career expectations in a fast-growing organization.
As a System Verification Engineer at Amaris Consulting, you will play a key role in planning and executing system-level verification activities for complex medical devices. You will ensure compliance with international standards and regulations, manage requirements traceability and defect resolution, prepare comprehensive test documentation, and collaborate closely with cross-functional engineering and quality teams to deliver high-quality solutions.
Your missions
Plan and execute system-level verification activities for complex medical devices in accordance with project requirements.
Develop and maintain verification strategies, protocols, and test cases ensuring compliance with IEC 60601, ISO 13485, ISO 14971, FDA, and MDR standards.
Perform requirements traceability, ensuring all system requirements are verified and validated.
Manage defect identification, reporting,
and resolution throughout the verification lifecycle.
Prepare and review comprehensive test documentation, including verification plans, reports, and traceability matrices.
Collaborate with cross-functional engineering and quality teams to ensure alignment on verification objectives and deliverables.
Support audits and regulatory submissions by providing verification evidence and documentation.
Contribute to continuous improvement of verification processes and methodologies.
Your profile
Experience in system verification and validation of medical devices.
Experience with IEC 60601, ISO 13485, ISO 14971, FDA, and MDR requirements.
Experience with requirements traceability and defect management tools.
Experience with test documentation and regulatory submissions.
Academic background: engineering, biomedical engineering, or related field.
English and Italian fluent.
You demonstrate strong analytical and communication skills.
Wha