Test Engineer Lazio

Test Engineer
Roma
Lazio, Lazio

Join the SaMD Team to ensure the robust testing and validation of Software as Medical Devices (SaMD) in adherence to regulatory standards and quality requirements.

Key Responsibilities: Software Testing and Validation: Maintain test strategies and frameworks for SaMD.

Collaborate proactively with cross-functional teams, including Electronics, AI, Mechanical, and Quality.

Create and refine user needs, risk management, and product requirements, outlining plans for verification and validation.

Identify and mitigate project risks in collaboration with the project teams.

Interface with internal and external stakeholders, suppliers, manufacturers, and customers.

Collaboration and Project Management: Collaborate effectively with project teams and various engineering skillsets throughout all stages of development.

Ensure seamless integration of software components with other modules and systems.

Qualification – Required Knowledge, Skills, and Abilities: Full understanding of Design Control processes in the context of medical device development.

Proficiency in C and C++ (minimum 3 years of development experience).

Knowledge of Python and Bash.

Basic understanding of computer architecture, operating systems (especially Linux), and system libraries.

Ability to design and develop data structures and integrate proprietary software with third-party applications.

Knowledge of computational complexity and expertise in multi-threaded application design and development.

Experience with key synchronization techniques and tools.

Familiarity with the design and development of modules for the Linux kernel.

Basic understanding of electronic-based technologies, especially in the context of medical devices.

Effective stakeholder engagement skills and demonstrated problem-solving abilities.

Ability to work under stress and meet tight deadlines.

Minimum Required Education and Experience: Master's Degree in Physics, Mathematics, Computer Science, or Software Engineering (PhD is a plus).

Minimum of 5 years of experience with C and C++ (mainly standard library) and basic knowledge of Python and Bash.

Experience with GPU programming (CUDA) is advantageous.

Knowledge of ISO, regulatory, and legislative standards applicable to the development of medical devices.

Fluent in English, both written and spoken.

Familiarity with ISO, regulatory, and legislative standards applicable to the development of medical devices is a plus.

Physical Requirements - Expected travel is 30% We support equal opportunities, without any discrimination; The research complies with Legislative Decree 198/2006