C# Developer

Senior C# Developer

Headcount - 02

Location: Onsite - Pittsburgh (PA) US

Desired Start Date: ASAP

Indianola PA

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:

• Bachelors or Masters 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.