System Verification Engineer

Amaris Consulting; Mirandola; Ibrido; EUR 26.000 - 50.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid work model

Internal Academy training

Global exposure

WeCare Together program

Descrizione del lavoro

Amaris Consulting is seeking a System Verification Engineer to join our international team in Mirandola, Italy. You will plan and execute system-level verification for complex medical devices, ensuring compliance with IEC 60601, ISO 13485, ISO 14971 and MDR.

We offer a hybrid work model from Mirandola, with a local salary range and opportunities to grow within a global organisation. You will collaborate with engineering and quality teams and contribute to continuous process improvements.

Competenze

• Plan and execute system-level verification activities for medical devices.
• Develop and maintain verification strategies, protocols, and test cases.
• Ensure compliance with IEC 60601, ISO 13485, ISO 14971, FDA, and MDR.
• Perform requirements traceability and verify/validate system requirements.
• Manage defect identification, reporting and resolution.
• Prepare test documentation including verification plans and reports.
• Support audits and regulatory submissions with verification evidence.
• Contribute to continuous improvement of verification processes.

Mansioni

• Plan and execute verification activities per project requirements.
• Collaborate with cross-functional teams to align objectives.
• Provide verification evidence for audits and submissions.
• Maintain comprehensive test documentation and traceability matrices.

Conoscenze

System verification

Requirements traceability

Test documentation

Regulatory submissions

Analytical skills

Communication skills

English

Italian

Formazione

Engineering

Biomedical engineering

Related field

Strumenti

Traceability tools

Descrizione del lavoro

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.

What we offer

• An international community, bringing together 110+ different nationalities
• An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
• A robust training system with our internal Academy and 250+ available modules
• At Amaris, sustainability is part of everything we do. You’ll have the opportunity to turn your ideas into action and make a tangible impact. Every day, our teams bring our ESG commitments to life, from reducing our footprint to driving positive change within our communities. Through our WeCare Together program, you’ll be empowered to design and lead projects that create real social or environmental impact, with the company’s full support.
• Gross Annual Salary (GAS): EUR 26,000- EUR 50,000 ; basic salary only, the variable component will be detailed in the offer
• We welcome applications from experienced freelancers.
• Remote policy: Possibility to work in a hybrid model from Mirandola (on-site and remote days per week, to be defined according to project needs)

Amaris Consulting is proud to be an equal-opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.