R&D Software Engineer

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.
• 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%.

Company

BVI is refocusing the future of vision.

As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver (Knives and Blades), Visitec (Cannulas), Malosa (Single-Use Instruments), Vitreq (Vitreoretinal Surgical Products) and PhysIOL (Premium IOLs), andspans more than 90 countries.

We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.

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