We are looking for a Senior Medical Device Software Engineer with a strong background in software development, technical documentation, and quality assurance processes. The ideal candidate will possess in-depth knowledge of software requirements and design specifications, software risk analysis, and expertise in designing comprehensive verification and validation tests.
Develop and maintain software for neuromodulation and EEG devices, ensuring performance, safety, and compliance with medical device standards and regulations.
Author high-quality technical documentation, including software requirements specifications (SRS), software design specifications (SDS), and test protocols.
Conduct software risk analysis to identify potential issues and develop mitigation strategies, ensuring patient safety and device effectiveness.
Review verification and validation tests for software functionalities, ensuring compliance with both internal standards and external regulatory requirements.
Collaborate with cross-functional teams, including product owners, hardware engineers, clinical researchers, and regulatory affairs, to ensure cohesive development and documentation efforts.
Stay abreast of industry trends, regulatory changes, and advancements in technology to continually improve our software development and documentation practices.
Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field. A Master's degree is preferred.
Minimum of 4 years of experience in software development for medical devices, with a strong portfolio demonstrating expertise in technical documentation and quality assurance.
Expertise in C/C++ and Python. Knowledge of GUI programming for Desktop applications.
Knowledge about the development of desktop applications with GUI using C++, C#, Java or others.
Familiarity with the Qt framework.
Knowledge of cloud/web technologies (Azure/AWS, SQL Server, REST, Flask...).
Working knowledge of Matlab.
Knowledge of regulatory standards applicable to medical device software development, such as IEC 62304, ISO 14971, ISO 81001-5-1, FDA guidelines, and European regulations (MDD, MDR, etc.).
Demonstrated experience with software requirements specification (SRS), software design specifications (SDS), software risk analysis, and the creation of verification and validation tests.
Excellent analytical, problem-solving, and communication skills, with the ability to explain complex technical concepts to non-technical stakeholders.
Familiarity with modern software development tools, languages, and methodologies.
Strong attention to detail and commitment to delivering high-quality, compliant software solutions.