Purpose

Join the Quality Engineering Team to support development and production of Intelligent Medical Devices

Work Location: Rome – Italy – Viale Ostiense 131/L

Key Responsibilities

• Software and Hardware Verification & Validation
• Development and management of technical documentation
• Ensure that the design team develops the product according to Operating Procedures
• Draft and/or revise procedures and checklists for production (e.g., assembly, software installation, product release…)
• Draft and revise protocol for end-of-line testing
• Label management and control
• Documentation management and review: archiving, maintaining a file for checking produced serials
• Design transfer and training activities
• CAPA management: non-conformance management and compliant, root cause analisys

Qualification – Required Knowledge, Skills and Abilities

• Knowledge of IEC/EN 60601-1 and IEC/EN 60601-1-2
• Knowledge of IEC 62304
• Knowledge of 2017/745(MDR) and 21 CFR 820
• Knowledge of 21 CFR part 11
• Ability to write and review all project related Documentation (FRS, SRS, SDS, HRS, HDS, etc.)
• Familiarity with medical software development and software development processes in compliance with regulations.

Minimum Required Education and Experience

• 3+ Experience in the role (highly desirable)
• Life science or Engineering education
• Knowledge of ISO 9001, ISO 13485, 93/42/CEE (MDD)
• Good English Level (writing and speaking)

Physical Requirements

• Expected travel is 20%

Work Location: Lainate (MI) – Italy – Via Cristoforo Colombo 1

Responsibilities:

• Collaborate with senior AI engineers and cross-functional teams to develop and implement AI solutions for medical devices.
• Assist in designing, developing, and testing AI algorithms, models, and systems.
• Support the integration of AI technologies into existing medical devices and systems.
• Stay up-to-date with the latest advancements in AI, machine learning, and computer vision.
• Participate in code reviews, troubleshooting, and optimization efforts.
• Document and communicate technical concepts and solutions effectively.

Requirements:

• Bachelor’s or Master’s degree in Computer Science, Engineering, or a related field.
• Solid understanding of machine learning, computer vision, and deep learning concepts.
• Proficiency in programming languages such as Python or C++.
• Experience with popular AI frameworks and libraries like TensorFlow, PyTorch, and Scikit-learn.
• Familiarity with data preprocessing, feature engineering, and model evaluation techniques.
• Knowledge of statistical analysis and data visualization tools.
• Strong problem-solving and analytical skills.
• Excellent communication and teamwork abilities.
• Proactive and self-motivated with a strong desire to learn and grow.

Preferred Qualifications:

• Demonstrated involvement in AI-related projects or research (e.g., coursework, internships, personal projects, publications, contribution to open-source projects).
• Knowledge of medical imaging analysis, signal processing, or healthcare data management.

We support equal opportunities, without any discrimination.

The research complies with Legislative Decree 198/2006

Purpose:

Lead the Technical Service activities to support the production and maintenance of Intelligent Medical Devices

Work Location: Rome – Italy – Viale Ostiense 131/L

Key Responsibilities: 

• Lead the service team
  • Create an inspiring team environment with an open communication culture
  • Motivate team members
  • Oversee day-to-day operation
  • Encourage commitment
• Provide support and training to customers
• Provide support and coordinate tasks in the production line and in the service center
• Problem-solving and reporting
• Proactively collaborate with other teams (Electronics, Mechanical, Software, Quality)

Qualification – Required Knowledge, Skills and Abilities

• At least 5 years of experience in the technical support of medical devices or electromechanical equipment.
• Analytical approach in problem-solving with the root cause analysis and investigation
• Deep knowledge of Linux Operative system
• Work collaboratively with the other members of the team and the external suppliers.
• The plus will be the knowledge of one or more of the following standards:
  • ISO 9001
  • ISO 13485
  • ISO 27001
  • IEC 60601-1 e 60601-1-2

Minimum Required Education and Experience

• Technical education, a master’s degree will be a plus
• English language speaking
• Problem-solving attitude
• Good soft and relationship skills

Physical Requirements

• Expected travel is 40% in Italy, 10% RoW

Project Description

In partnership with the Artificial Intelligence Research Centre (CitAI) at City, University of London, Cosmo Intelligent Medical Devices is funding a Ph.D. Studentship on Endoscopic Video Analysis. The Ph.D. project offers the opportunity to investigate and pursue research in machine learning applied to endoscopy, with access to Cosmo IMD computational facilities and a proprietary library of annotated endoscopy videos. These datasets are unprecedented in size, quality, and heterogeneity and will offer an exclusive real-world benchmark for self-supervised and fully supervised learning approaches.

About the Studentship

We seek outstanding Ph.D. candidates with a strong interest, enthusiasm, and high potential in machine learning research for medical imaging applications. Applicants are typically expected to have a first-class, distinction, or high upper-second-class degree in relevant subjects, including computer science, mathematics, engineering, physics, or another discipline relevant to their Ph.D. project proposal.

The project will be carried out at The Artificial Intelligence Research Centre (CitAI) at City, University of London, in collaboration with Cosmo IMD. City University has a demonstrated high-quality research output, with over 75% of its studies rated as world-leading research. The Ph.D. studentship will be funded for three years and includes tuition fees for home students and a highly competitive tax-free stipend.

For further details please visit this web page.

Purpose:

Lead the SaMD (Software as Medical Device) Team

Work Location: Rome – Italy – Viale Ostiense 131/L

Key Responsibilities: 

• Lead the SW team:
  1. Create an inspiring team environment with an open communication culture
  2. Set clear team goals
  3. Motivate team members
  4. Oversee day-to-day operation
  5. Discover training needs and provide coaching
  6. Encourage creativity and risk-taking
• Design, develop and maintain SW as Medical Devices.
• Proactively collaborate with other teams (Electronics, AI, Mechanical, Quality)
• Create and iterate user needs, risk management, and product requirements while identifying plans for verification and validation
• Identify and mitigate project risks
• Interface with internal and external suppliers, manufacturers, and customers
• Work collaboratively with project teams and engineering skillsets through all stages of development

Qualification – Required Knowledge, Skills and Abilities

• Full understanding of Design Control
• C and C++ are a must (at least 3 years development experience)
• Python and Bash are a plus
• Basic knowledge of computer architecture
• Basic knowledge of operating systems and in particular Linux
• Knowledge of system libraries and the Posix standard
• Ability to design and develop data structures
• Knowledge of the main compilation tools
• Ability to compile third-party libraries, archives, etc.
• Ability to integrate proprietary software with third-party software
• Knowledge of computational complexity
• Ability to analyze problems and synthesize algorithms
• Multi-threaded application design and development
• Knowledge of key synchronization techniques and tools
• Design and development of modules for the Linux kernel
• Knowledge of medical device specialization with strong understanding of electronic based technologies
• Demonstrated ability to effectively engage key Stakeholders
• Effectively utilize problem solving skills and techniques to identify potential issues, assess their impact, and develop and implement mitigation and resolution plans and activities
• Ability to work under stress and under time constraints.

Minimum Required Education and Experience

• Master Degree in Physics, Mathematics, Computer Science, or Software Engineering (PhD is a plus).
• At least 5 years of experience with C and C++ (mainly standard library), and a basic knowledge of Python and Bash. Experience with GPU programming (CUDA) is a plus
• Knowledge of ISO, regulatory and legislative standards applicable to the development of medical devices
• Fluent English, written and spoken.
• Knowledge of 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

Purpose

Responsible for the electronic design and development of Intelligent Medical Devices

Work Location: Rome – Italy – Viale Ostiense 131/L

Key Responsibilities

• Proactively collaborate with other teams (AI, Mechanical, Quality)
• Work across functions and team boundaries to define, design, and implement the next generation of products.
• Create and iterate user needs, risk management, and product requirements while identifying plans for verification and validation
• Identify and mitigate project risks
• Interface with internal and external suppliers, manufacturers, and customers
• Work collaboratively with project teams and engineering skillsets through all stages of development
• Ensure regulatory, statutory, and legislative compliance

Qualification – Required Knowledge, Skills and Abilities

• Comprehensive knowledge of medical device specialization with strong understanding of electronic based technologies
• Critical analysis of electronic boards
• Prototyping, testing, debugging, troubleshooting on electronic boards
• Knowledge of laboratory instrumentation
• Knowledge of PCB design and debugging tools, especially Altium.
• Integration of electronic boards into a system
• Interfacing with software, firmware and mechanical departments.
• Design of wiring diagrams of digital circuits (FPGAs and microcontrollers).
• Demonstrated ability to effectively engage key Stakeholders
• Effectively utilize problem solving skills and techniques to identify potential issues, assess their impact, and develop and implement mitigation and resolution plans and activities
• Full understanding of Design Control
• Experience with creation and full traceability across user needs, risk management, product requirements, and V&V
• Excellent interpersonal and communication skills with all levels of associates, management, and external partners
• Knowledge of Altium Designer.
• Knowledge of major communication protocols.
• Electromagnetic immunity and EMI-oriented design expertise.
• Knowledge of VHDL, C language.
• Knowledge of Xilinx development environment.
• Ability to work under stress and under time constraints.
• Excellent interpersonal skills.
• Aptitude for teamwork.
• Aptitude for continuing education.

Minimum Required Education and Experience

• Bachelor’s degree in electrical engineering.
• At least 5 years of electronic board prototyping experience
• Fluent English, written and spoken.
• Experience in electromedical products.
• Nice to have: Expertise on IEC 60601-1 and IEC 60601-1-2.
• Knowledge of ISO, regulatory and legislative standards applicable to the development of medical devices

Physical Requirements

• Expected travel is 30%

Purpose:

Responsible for the software design and development of Intelligent Medical Devices

Work Location: Rome – Italy – Viale Ostiense 131/L

Key Responsibilities: 

• Proactively collaborate with other teams (Electronics, AI, Mechanical, Quality)
• Work across functions and team boundaries to define, design, and implement the next generation of products.
• Create and iterate user needs, risk management, and product requirements while identifying plans for verification and validation
• Identify and mitigate project risks
• Interface with internal and external suppliers, manufacturers, and customers
• Work collaboratively with project teams and engineering skillsets through all stages of development

Qualification – Required Knowledge, Skills and Abilities

• Good knowledge of the Linux operating system and its system libraries
• Experience with compilation and integration of proprietary and third-party software
• Experience with multi-threaded applications
• Good knowledge of English, written and spoken
• Very good problem solving skills
• Ability to work on different projects, sometimes under time constraints

Minimum Required Education and Experience

• Master Degree in Physics, Mathematics, Computer Science, or Software Engineering (PhD is a plus).
• At least 3 years of experience with C and C++ (mainly standard library), and a basic knowledge of Python and Bash. Experience with GPU programming (CUDA) is a plus
• Knowledge of ISO, regulatory and legislative standards applicable to the development of medical devices

Physical Requirements

• Expected travel is 30%