Our client, a multinational company that leads the Medical and Life Sciences sector, is looking for a Senior Software Engineer to join their R&D department in Rome.
This Engineer is responsible for a wide variety of engineering work in support of reprocessing medical devices including design and development of new products, processes and tooling. The ideal candidate has the technical skills and team leadership, engages internal and external capabilities as needed, to ensure that appropriate design and evaluation of reprocessed medical devices are implemented to ensure high quality and reliability.
The Senior Software Engineer is responsible for providing overall software systems design & architecture across complex electro-mechanical systems with embedded firmware and connectivity for Automated Endoscope Reprocessors (AER).
The essential duties and responsibilities are:
- Provide technical leadership for Systems Architecture, Software Design, Hardware interface and Connectivity solutions for medical device software.
- Define Requirements and Design specifications in collaboration with upstream Marketing, Standards bodies and Regulatory requirements.
- Provide deep technical expertise in Endoscope reprocessing technologies and Trace and Track systems, in accordance with IEC and AAMI standards.
- Create Architectural Design for developing software in C#, ASP.NET MVC, WPF & XAML, Entity Framework, with MS SQL Server interface.
- Lead platform software definition with microcontrollers, WiFi, Bluetooth and RFID technologies.
- Create Architectural Designs and prototype models for Proof of Concept and feasibility.
- Execute on meeting deliverables in accordance with New Product Development Phase Gate process.
- Develop plans for Human Factors Engineering and Usability Testing and coordinate execution by identifying and engaging key clinical personnel from internal groups and customer sites.
- Collaborate with Regulatory Affairs, Technical Services, and Manufacturing/Operations for hitting key milestones for New Product Development in alignment with R&D objectives and product direction.
- Lead & coordination of Qualification Protocols and Test execution across all aspects of Firmware and Software, including over Systems Validation, to ensure that the product meets requirements.
- Create and document all aspects of the software engineering processes for products, incorporating the highest quality standards in accordance with the QMS, cost effectiveness, and measurable efficiency.
- Provide guidance and best-practice techniques to meet all regulatory compliance requirements.
- Provide technical support for software deployment at Beta sites and work closely with Technical services group for troubleshooting and making enhancements.
- Lead and provide guidance in the development & testing of prototypes, verification/validation units and product specifications, including test development plans, test reports and input to risk analysis.
- Establish and perform or oversee the execution of software test plans, assess device limitations and determine acceptance criteria.
- Provide an effective bridge between software and hardware personnel and be responsible for the timely completion of the technical deliverables.
- Provide support to Marketing for Voice of Customer and new product launches in US and Europe.
- BS in Engineering or Computer Science and 8+ years related experience in software development in a Linux and/or Windows environment. Preferred MS in Electrical/Computer Engineering or Computer Science.
- Experience in Medical Device lifecycle development processes, particularly Medical Device SW.
- Familiar with Design Controls, AAMI and ISO standards.
- Systems Engineering experience for designing with technologies – C++, C, C#, .NET MVC, WPF & XAML, Entity Framework, SQL Server, Azure Dev Ops, Visual Studio & Git.
- Advanced understanding of project management principles to effectively complete assignments and achieve desired outcomes.
- Complete understanding and wide application of technical principles, theories and concepts in the field of Medical Electrical Equipment including tools and methodologies for software design and development, configuration management, project scheduling, problem resolution for the complete software development cycle.
- Must have excellent written and verbal communication skills in the English language.
- Ability to work successfully both independently and in a team environment.
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