Senior Developer (.NET/ C#)
Location: Onsite - Pittsburgh (PA)
Desired Start Date: ASAP
Contract- open for only W2
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.
please reach out to me : @Saksham@sitwinc.com
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