Ophthalmic MedTech R&D Software Engineer - On-site Rome

Physiol

Roma

Ibrido

EUR 55.000 - 75.000

Tempo pieno

4 giorni fa

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Descrizione del lavoro

PhysIOL is seeking an R&D Software Engineer to support maintenance, design and development of software for ophthalmic surgical devices based in Rome. You will drive software activities across the lifecycle and collaborate with Quality, Regulatory and Manufacturing to meet ISO 13485 and IEC 62304 requirements.

The role requires proficiency in C++, C#, Qt, WPF and Python, plus Linux/Windows experience; on-site work in Rome with up to 10% travel.

Competenze

Bachelor's degree in Informatics, Engineering, or a related field; Master's degree preferred.
Minimum 3 years of relevant experience in the medical device industry, or an equivalent combination of education, training, and experience.
Proficiency in C++, C#, Qt, WPF, and Python.
Experience with Linux and Windows preferred.
Experience with Qt Creator, Visual Studio, and Yocto preferred.
Knowledge of LinkQ and SQL.
Basic knowledge of ISTQB.
Experience in firmware development for electronic devices.
Experience operating in a regulated design controls environment, with knowledge of ISO standards and regulatory and legislative requirements applicable to software development for medical devices (e.g., ISO 13485, IEC 62304).
Strong communication and influencing skills.
Proactive and flexible, with a results-oriented approach and the ability to plan and deliver against project deadlines.
Excellent written and spoken Italian and English.
Must be able to work on-site in Rome, Italy.
Willingness to travel up to 10%.

Mansioni

Drive product development activities across all aspects of the software lifecycle.
Ensure compliance with applicable regulatory, statutory, and legislative requirements.
Collaborate with cross-functional teams, including Quality, Regulatory, Technical Transfer, Manufacturing, Procurement, Purchasing, and Service, throughout product development and the product lifecycle.
Direct and support the development of software product prototypes.
Organize exploratory testing as required.
Support Quality activities, including GxP compliance and complaint root cause analysis and resolution.
Support Regulatory activities by preparing technical documentation required by regulatory authorities, including specifications, verification and validation protocols and reports, and by executing verification and validation activities.
Interface with internal and external suppliers, manufacturers, and customers, as applicable.
Effectively communicate activity status, issues, and mitigation plans to key stakeholders.