The role of the Software Engineering Director entails supervising software and firmware development and documentation for various development projects.
Alongside strategic decision-making, the position involves direct engagement in software development, documentation, and testing. The incumbent will establish and administer top-tier software development standards to facilitate the creation of compliant medical device products aligned with applicable regulations. This position is based in Durham, NC.
What will you be doing?
- Implement design controls throughout the software development process
- Supervise software development contractors, including those overseeing cloud architecture
- Formulate software development plans and ensure adherence to the IEC 62304 standard
- Apply FDA cybersecurity guidance through total product lifecycle of product portfolio
- Actively participate in hands-on development and testing of software and firmware, encompassing the establishment of a unified codebase for medical device products
- Manage and maintain software tools to ensure their effectiveness
- Lead code reviews to ensure code quality and alignment with standards
- Generate and evaluate code unit tests to verify software functionality
- Apply principles of risk management throughout development process per IEC 14971
- Develop comprehensive software requirements to guide the development process
- Create software architecture and design documentation for clear project understanding
- any additional responsibilities as assigned
- Minimum of 10 years’ experience in software development and medical device innovation, accompanied by prior leadership and management involvement in guiding dynamic software development teams
- Technical proficiency in software and firmware design, application architecture, and software development using C, C++, and Python programming
- Familiarity with agile methodologies and adeptness in continuous delivery practices
- Exceptional communication skills, enabling effective collaboration with cross-functional teams
- Robust aptitude for analysis and adeptness in resolving intricate problems
- Familiarity with cloud-based infrastructure and contemporary software development practices
- Established track record of triumphantly delivering intricate software projects on schedule and within financial limits
- Previous exposure to startups or entrepreneurial ventures is an advantage in our pursuit of cutting-edge innovation
Target Start Date: Nov 2023
To apply, please send your resume and cover letter to email@example.com . We look forward to hearing from you!