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

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.