Verification & Validation Engineer – MD Classe IIa

Location:

Bologna, Emilia Romagna, Italy

Salary:

Negotiable

Type:

Permanent

Main Industry:

Search Manufacturing Jobs

Advertiser:

NonStop Consulting

Job ID:

132479250

Posted On:

26 November 2025

Verification & Validation Engineer (Dispositivi Elettromedicali Classe IIa)

Sede: Bologna

Dipartimento: R&D / Quality

Contract: Full time, Permanent

Duties and Responsibilities

* Responsible for the design verification and validation phases within the product development process. This includes preparing verification and validation plans/protocols, performing tests, and providing evidence of compliance with technical requirements and user needs through appropriate test reports.
* Ensure the correct application of IEC 62304 throughout the software lifecycle, taking into account software cybersecurity aspects and collaborating closely with the software development team.
* Actively contribute as a member of the Risk Management team to the implementation of the risk management process and to product risk analyses, including device security considerations.
* Support the design transfer phase by contributing to the definition of the Device Master Record (DMR).
* Operate in compliance with medical device standards and the company QMS, preparing all required documentation according to internal product development processes and regulatory requirements.
* Contribute to the maintenance and continuous improvement of the QMS with respect to design and development activities.

Requirements and Skills

* Degree in Software Engineering, Electronic Engineering, Biomedical Engineering, Computer Science, or related disciplines.
* 3-5 years of experience in the verification and validation of medical devices involving software, electronics, and mechanics.
* Experience in drafting test plans, test protocols, and test reports.
* Ability to conduct code reviews in one or more of the following programming languages: C#, .NET Core, Dart, Flutter.
* Direct experience with therapeutic devices for ophthalmology, dermatology, or physiatry (e.g., pulsed light, laser, LED, radiofrequency, or stimulation devices).
* Knowledge of MDR 2017/745, ISO 13485:2016, IEC 62304, IEC 62366-1, IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 10993, and AAMI TIR57.
* Knowledge of the design control process in accordance with CFR 21 §820.30.
* Excellent command of technical English, both written and spoken; documentation will be primarily in English.
* Strong problem-solving skills and decision-making ability.
* Self-directed and capable of guiding others when needed.
* Excellent communication skills.
* Ability to collaborate effectively with multidisciplinary teams.

Preferred Skills (Nice to Have)

* Familiarity with photobiology testing, optical and thermal energy parameters, and principles of phototherapy or neuromuscular stimulation.
* Knowledge of the ANSI/AAMI Z80.36 standard.
* Proficiency in one or more of the following programming languages: C#, .NET Core, Dart, Flutter.
* Experience with data acquisition and test automation tools (LabVIEW, Python, MATLAB).

If this opportunity aligns with your experience and career goals, you can here or send your CV to me, Aurora Ranaldi, via the NonStop Consulting website or on my LinkedIn profile.

If you feel that your profile matches most of the requirements, even with some differences from the job description, please still send your CV and we can evaluate it directly with the company.

If this role isn’t a perfect fit for you, feel free to share it with anyone in your network who might be interested.

About NonStop Consulting: We are NonStop, a leading provider of staffing solutions throughout Europe and now also in the US. We’re passionate about connecting talent with opportunity and work non-stop to support our clients in hiring the best talent for their teams. Feel free to pop over to our website, NonStop Consulting (nonstopconsulting), for more information, to browse all our roles, or to let us know how we can help you.

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