Description

Lead the architectural design and development of compliant C#/.NET software for Class II medical devices.

This role is on-site.

Responsibilities

• Lead the design and development of scalable software aligned with system requirements and risk controls.
• Drive the creation of design documentation, risk assessments, and software traceability per IEC 62304.
• Serve as a technical liaison between software, systems, QA, regulatory, and hardware teams.
• Mentor junior and mid-level developers while enforcing coding standards and software lifecycle processes.
• Conduct code reviews, technical walkthroughs, and root cause investigations.

Required Skills

• 6+ years of professional software development experience with C#/.NET.
• Proven experience in regulated product development for Class II or Class III medical devices.
• Practical experience with IEC 62304, ISO 14971, and FDA QSR/21 CFR Part 820.
• Expertise in OOP, multithreading, software design patterns, and dependency injection.
• Proficiency with Visual Studio, Azure DevOps, and Git.
• Bachelor’s or Master’s degree in Computer Science or Software Engineering.
• Ability to produce high-quality technical documentation and design artifacts.
• Experience working in Agile or hybrid (Agile + V-model) environments.

Preferred Skills

• Experience developing WPF, WinForms, or cross-platform GUIs for medical devices.
• Familiarity with DICOM, HL7, Bluetooth, USB, or other healthcare communication protocols.
• Knowledge of medical device cybersecurity and FDA premarket guidance.

Key Skills

Education

Bachelor’s or Master’s degree in Computer Science, Software Engineering