Overall responsibility for the current and future software design, development, and architecture which delivers software solutions and meet regulatory and product management requirements.
Overall responsibility for operation and maintenance of all software development and testing tools (LSIDE) necessary to achieve Product Realization and regulatory clearance
Leads the Company’s Software development and testing teams, including contributing to the application codebase, and participating in design, test plan, code, and documentation reviews
Researching, designing, coding, testing, and implementing computation algorithms which will deliver a competitive advantage to the Company
Ensuring quality software integration into the overall functions of current software products, including data integration
Designing and Developing features desired by customers and participating in prioritization process
Developing and maintaining software architecture and software design
Developing and documenting system specifications and translating system requirements into design specifications
Participating in code analysis and reviews
Performing risk analysis
Supporting the Quality System through documentation of system requirements, interfaces, architecture and design, enabling ongoing CE marking and FDA clearance
Qualifications:
Bachelor’s Degree in Computer Science or comparable field, with 4 years of related experience
Minimum 4 years of successful experience leading teams of software developers
Experience in implementing computational algorithms in medical device software required
Experience in the field of Radiation Therapy is highly desired
Proven leadership skills in leading remote teams
Proven hands-on experience in the technical management of complex software projects, including planning, execution, and quality assurance
Programming experience in C++ or C# or equivalent is required. Experience with the Qt Framework and Typescript/React is highly desired
Experience using design and development methodology
Experience with medical imaging techniques (CT, MRI, PET), formats (DICOM), 3D graphics and image analysis is a plus
Experience with object-oriented analysis and design methods is desired, with knowledge of UML a plus
Experience with verification and validation of medical devices is preferred.
Experience with file management and relational database management systems is beneficial.
Experience with Visio and Project Planning software a plus
Environments: Windows, Mac OS, Unix variants
Knowledge of FDA QSR design control requirements (21 CFR Part 820.30) is beneficial
Good interpersonal skills and fluency in English
Good communication and documentation skills are required
Experience with working under a matrixed organization is beneficial
United States of America Citizenship or be able to work legally in the United States of America and present documents verifying immigration status