Software Engineering Manager

2 weeks ago

Cleveland, Ohio, United States MediView XR, Inc. Full time
Software Engineering Manager

MediView XR, Inc. is revolutionizing surgical guidance and navigation with Augmented Reality (AR) and Artificial Intelligence (AI). We are seeking a seasoned Software Engineering Manager to lead our medium-sized distributed software development team through the entire software development lifecycle across multiple concurrent projects.

Key Responsibilities:
  • Manage a team of skilled Software Engineers
  • Participate in project planning, requirements gathering, verification, and documentation
  • Represent the software function in project core teams
  • Mentor the team in software and medical device development
  • Collaborate with development and regulatory functions to ensure Design Controls compliance
  • Participate in risk management activities and contribute to regulatory submissions/audits
  • Responsible for maintaining and updating software development SOPs
  • Lead the Agile process and drive hands-on development of user stories, design discussions, and code reviews
  • Work with project team members to coordinate project scope, activities, and engineering team bandwidth
  • Perform other activities required to achieve 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
  • Agile development experience: sprint planning and Scrum
  • Ability to effectively work with a distributed development team
  • Experience with Medical Imaging, DICOM, PACS, Unity, and/or 3D graphics development, AR/XR/VR, and Software cybersecurity (including FDA cybersecurity guidelines) is a plus
  • Some travel may be required, including overnight stays

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