10 set - Roma
Physiol
We are seeking an R&D; Software Engineer to support the maintenance, design, and development of software products for ophthalmic surgical devices. This role will drive software development activities throughout the product lifecycle, working cross-functionally to ensure compliance with applicable quality and regulatory requirements and supporting the development of products from concept through commercialization.
Key Responsibilities
- 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.
Qualification
- 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.
- Expe
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