MediView is building the future of surgical guidance and navigation with Augmented Reality (AR) and Artificial Intelligence (AI). The Software Engineering Manager will be a hands-on software development manager that can lead a medium sized (but growing) distributed software development team through the entire software development lifecycle across multiple concurrent projects.
DUTIES AND RESPONSIBILITIES:
- Manage a team of Software Engineers
- Participate in the software development lifecycle: project planning, requirements, verification and documentation
- Represent the software function in project core teams
- Mentor the team in software and medical device development
- Work with development and regulatory functions to follow and implement Design Controls
- Participate in risk management activities and collaborate with regulatory submissions/audits
- Responsible for maintaining and updating the software development SOPs
- Be a leader in the Agile process
- Hands-on role in development of user stories, design discussions, and code reviews
- Work with members of the project team(s) to coordinate project scope, activities and bandwidth of engineering team
- Perform other activities required to achieve the company goals.
REQUIREMENTS/QUALIFICATIONS:
- Bachelor's degree in Computer Science, Computer Engineering, Software Engineering, or related field
- Previous experience leading software teams through the full software development lifecycle.
- Medical device software development experience.
- Real world experience with IEC 62304 and working under Design Controls/FDA QMS/ISO 13485.
- Extensive software development experience, likely as a lead developer in previous roles. Knowledge of C# and C++.
- Agile development experience: sprint planning and scum.
- Capable of effectively working with a distributed development team.
- Experience with the following is as plus: Medical Imaging, DICOM, PACS, Unity and/or 3D graphics development, AR/XR/VR, Software cybersecurity (including the FDA cybersecurity guidelines)
- Some travel may be required including overnight stays.
