C# Developer

Must Haves:

1) 6+ years of professional software development experience with C#/.NET.

2) Proven experience in regulated product development, specifically Class II or Class III medical devices.

3) Strong understanding and practical experience with IEC 62304, ISO 14971, and FDA QSR/21 CFR Part 820.

Nice to Have/Additional Comments: Developing WPF, WinForms, or cross-platform GUIs for Medical Devices, Familiarity with DICOM, HL7, Bluetooth/USB, or other healthcare communication protocols

Job Description:

We are looking for a Senior C# Developer to lead the development of software applications for a Class II medical device. This role requires a deep understanding of .NET development, medical device regulatory standards, and software architecture design. The ideal candidate will play a key role in defining technical direction, mentoring junior developers, and ensuring full compliance with regulatory standards such as IEC 62304, ISO 14971, and FDA 21 CFR Part 820.

Key Responsibilities:

• Lead the design and development of robust, scalable, and compliant C#/.NET software for a Class II medical device.
• Own architectural decisions and guide implementation to align with system requirements and risk controls.
• Serve as the technical liaison between software, systems, QA, regulatory, and hardware teams.
• Define and enforce best practices for coding standards, documentation, version control, and software lifecycle processes.
• Drive the creation of design documentation, risk assessments, and software traceability in accordance with IEC 62304.
• Conduct and lead code reviews, technical walkthroughs, and root cause investigations.
• Mentor junior and mid-level developers; promote a culture of engineering excellence and continuous learning.
• Support verification and validation efforts, participate in hazard analyses, and ensure mitigation strategies are implemented.
• Contribute to project planning, estimation, and status reporting in Agile or hybrid (Agile + V-model) environments.

Required Qualifications:

• Bachelor’s or Master’s degree in Computer Science, Software Engineering, Biomedical Engineering, or related discipline.
• 6+ years of professional software development experience with C#/.NET.
• Proven experience in regulated product development, specifically Class II or Class III medical devices.
• Strong understanding and practical experience with IEC 62304, ISO 14971, and FDA QSR/21 CFR Part 820.
• Deep expertise in OOP, multithreading, software design patterns, and dependency injection.
• Demonstrated ability to produce high-quality technical documentation and design artifacts.
• Proficient in development tools such as Visual Studio, Azure DevOps, Git, and unit testing frameworks.

Preferred Qualifications:

• Experience developing WPF, WinForms, or cross-platform GUIs for medical or laboratory devices.
• Familiarity with DICOM, HL7, Bluetooth/USB, or other healthcare communication protocols.
• Exposure to cybersecurity for medical devices, including secure coding and FDA premarket cybersecurity guidance.
• Hands-on experience with test automation, CI/CD pipelines, and software validation tools in regulated environments.
• Experience with system-level integration, including interactions with hardware, firmware, and cloud services.

Soft Skills & Leadership Traits:

• Strong communication and stakeholder engagement skills.
• Proven ability to lead, mentor, and elevate team capabilities.
• High level of attention to detail and a proactive approach to risk mitigation.
• Comfortable working in a dynamic environment with shifting priorities and evolving regulatory expectations.