Softvery Solutions

Project context
We are looking for an experienced FDA Consultant / FDA Submission Mentor for a medical device / healthcare software project.
The project already has a QA executor candidate, but the team needs a senior expert who can guide the FDA-related documentation process and ensure that all documents are prepared correctly and in the required format.

Main goal
We need a specialist with real hands-on experience in FDA submissions, who understands FDA rules and regulations and can either:

• take responsibility for preparing the FDA-related documentation package directly;or
• mentor and guide the QA specialist so that the documentation is prepared correctly and according to FDA expectations.

Responsibilities

• Advise the team on FDA submission requirements and documentation structure.
• Review and guide the preparation of FDA-related QA documentation.
• Help define what documents are required and how they should be prepared.
• Mentor the QA specialist on correct documentation format and process.
• Review documentation drafts and provide practical feedback.
• Help ensure that the documentation package is complete, consistent, and aligned with FDA expectations.
• Support the team in understanding regulatory and QA documentation requirements for a medical device / healthcare product.

Must-have requirements

• Real practical experience with FDA submissions.
• Previous participation in real FDA submission processes, not only theoretical knowledge.
• Strong understanding of FDA requirements, rules, and regulatory documentation.
• Experience preparing, reviewing, or managing FDA-related documentation packages.
• Experience with medical device and/or healthcare software projects.
• Ability to work as a consultant / mentor.
• Strong ownership and ability to guide the team without heavy supervision.
• Good English communication skills.

Nice to have

• Experience with FDA 510(k) submission.
• Experience with QA documentation for medical device software.
• Experience mentoring QA engineers.
• Experience working with startups or small product teams.
• Knowledge of traceability matrices, test documentation, validation documentation, risk-based testing, STP / STD / STR / ATP.

Expected format
Part-time / consulting / mentorship format.
The exact engagement format is flexible and can depend on the candidate’s availability and experience. The key requirement is proven hands-on experience with real FDA submissions.

Who We Are

We are looking for a Senior Desktop Engineer with strong WinUI 3 expertise to take ownership of our Windows desktop application and help shape a modern, high-performance medical product.

Our client is building an AI-powered medical decision-support product and is looking for a WinUI 3 Engineer to join the team and take ownership of a modern Windows desktop application.

What Youʼll Do

• Design and develop a modern Windows desktop application using WinUI 3
• Build responsive, high-performance UIs for real-time medical workflows
• Implement clean MVVM architecture and reusable UI components
• Collaborate closely with backend, AI, product, and design teams
• Improve performance, stability, and usability of the application
• Write and maintain technical documentation
  
  
  Requirements
• 3+ years of professional C# desktop development
• Strong hands-on experience with WinUI 3 (required)
• Solid understanding of MVVM architecture
• Experience with multithreading / async programming / IPC in Windows applications
• Strong knowledge of software design patterns
• Experience with unit testing in C#
• Experience building and maintaining Windows installers (MSI or similar)
• Experience working in mixed C# + Python environments (integration level)
  
  Nice-to-Have (Not Mandatory)
• Experience with Python
• Experience with REST or gRPC
• Experience in medical, healthcare, or regulated environments
• Knowledge of application security best practices
• Experience with kiosk-mode or controlled-environment applications
• Experience with distributed or real-time systems
  
  Personal
• Strong attention to detail and code quality
• Comfortable working in a startup environment
• Proactive, self-driven, and solution-oriented
• Clear communicator, able to collaborate across technical and non-technical teams
• Willingness to take ownership and influence product quality
  Why Join Us
• Work on a meaningful medical product with real clinical impact
• High level of technical ownership
• Modern stack with WinUI 3 and AI integration
• Remote-friendly, flexible environment
• Opportunity to shape the future of the desktop application architecture