iVis Technologies designs, manufactures and supports advanced ophthalmic systems for refractive surgery. Our 4D Suite platform is installed in surgical centres across more than thirty countries.
Reporting directly to the CEO and part of the leadership team, the Chief Technology Officer owns the entire technical life of our products from the algorithms that generate our treatment profiles to the performance of every system installed in the field. The role leads the R&D team directly and gives technical direction to Production, Service and Supply Chain, ensuring that what we design is manufacturable, serviceable and compliant with the standards of the medical device sector.
Key responsibilities R&D and product- Coordinates the R&D team and own the technology roadmap and product architecture (software, electronics and embedded, mechanics, system integration).
- Govern the software development lifecycle, code and design quality, and design control documentation.
- Evaluate technologies, partnerships and make-or-buy decisions on subsystems.
- Coordinates all the Production functions across electromechanical assembly and CNC milling; ensure adherence to the production plan in time, cost and quality.
- Drive Lean Manufacturing (5S, Kaizen, Kanban, SMED, VSM) and monitor production KPIs (OEE, cycle times, scrap, on-time delivery).
- Own the industrialisation of new products and engineering change control.
- Coordinate the Field Service function: installation, commissioning, maintenance and hardware/software upgrades of the installed base.
- Own service KPIs: first-time-fix rate, resolution time, installation lead time, installed-base uptime.
- Ensure field feedback feeds back into product development.
- Drive supplier qualification, technical specifications and supply issue management.
- Contribute to demand planning and manage supply risk on critical, long-lead components.
- Ensure compliance in your areas with MDR (EU) 2017/745, ISO 13485, ISO 9001, EN 60601-1, EN ISO 10993-1 and applicable safety regulations, in cooperation with Quality and Regulatory Affairs.
- Proven experience leading multidisciplinary R&D teams and directing production and service functions.
- Ability to translate clinical and commercial needs into product architecture and roadmap.
- Budget ownership, team development and change management in a growing, entrepreneurial environment.
- Full software development lifecycle, from requirement analysis and architectural design to implementation, testing and maintenance, with accurate technical documentation.
- Object-Oriented Programming, design patterns and SOLID principles for scalable, maintainable architectures.
- C, C++ and C#; Microsoft .NET and .NET Core; Visual Studio.
- Numerical computation and computational modelling; applied optics and ray tracing techniques.
- Solidworks, including drafting of mechanical components with production-grade tolerances for prototyping and manufacturing.
- CNC machine programming; from single part to full-system integration.
- Microcontroller-based embedded systems; schematic and layout design with Altium Designer.
- Communication protocols: RS232, RS485, USB, I2C, SPI and custom interfaces; C programming.
- CNC machining and electromechanical assembly; Lean Manufacturing and continuous improvement.
- Field troubleshooting of electro-medical equipment; reading of schematics and block diagrams.
- ERP/MES/MRP systems and supply chain fundamentals.
- MDR (EU) 2017/745, ISO 13485, ISO 9001, EN 60601-1, EN ISO 10993-1; design control and technical documentation.
- Degree in Engineering (Computer, Electronic, Mechanical, Mechatronic or Biomedical) or proven equivalent experience.
- Fluent written and spoken English; Italian.
- Lean Six Sigma certification (Green/Black Belt).
- Experience in ISO 13485-certified companies and in the ophthalmic, laser or optoelectronic field.
- Knowledge of image processing tools and software.
- Familiarity with post-market surveillance and vigilance processes.
- Additional foreign languages.
The contract and salary terms will be determined based on the skills, competences and experience of the candidate.
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Dettagli di contatto:
Team di recruiting di IVIS Technologies s.r.l.