Within the technical team, you will be responsible for the design and development of part of the medical devices (Contrast Media devices, medical IT applications), developed by our client, in accordance with medical normative requirements and in particular the standard: IEC 62304.
You have the technical expertise that ensures your autonomy, a taste for communication and teamwork, the ability to design innovative solutions while respecting time, cost and security requirements.
- From the product specifications, write, improve and update the software functional specifications and software detailed description for medical devices
- Design and develop software as specified, in accordance with IEC 62304, IEC 82304 and IEC 62366
- For software already installed in the field, when anomalies or new requests are reported, participate in the analysis of the request, search for the root causes in case of unexpected event, document and develop the changes decided in cross-functional teams (Marketing, R&D, Regulatory, Quality).
- Participate in the validation of the overall architecture of software and in the review of documents from other teams (V&V, interfaces, etc.)
- Participate to verification and validation effort, ensure efficient, robust and high coverage test strategy
- Collaborate with Quality and Regulatory team for impact analysis, software risk or quality assessment and provide support in case of audit
- Make propositions and contribute to the R&D process optimization
- Proficiency in C# or a significant expertise in object-oriented programming,
- Proficiency in database modulization and management (MS SQL Server)
- Relevant experience with windows technologies such as .NET framework, WCF, etc.
- Strong documentation and writing skills and ability to follow Quality and Regulatory requirements, prepare DHF and Technical Files
- Experience working with software methodologies (such as V-Cycle, Agile, TDD, BDD)
- Relevant experiences in software development and modular architecture design (UML, SOA, MVVM, design patterns, good development practices)
- Relevant experience in Source version control (GIT), Continuous integration (Jenkins, Gitlab CI), Bug tracking systems, Unit testing frameworks (MsTest, NUnit, Specflow, LDRA),
- Fluent in French and English