descrizione del lavoro

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