15 set - Roma
BVI Medical
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.
Drive product development activities across all aspects of the software lifecycle.
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.
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).
Proactive and flexible, with
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