15 ott
|
Physiol
|
Latina
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. * Experi
📌 R&D Software Engineer (Latina)
🏢 Physiol
📍 Latina