Senior Software Architect for Medical Device/Biotech Space

Job Description:
We are seeking a Senior Software Architect with a strong background in software design, reengineering, and architecture for the medical device or biotech industry. The ideal candidate will provide technical leadership, drive the design process, and ensure compliance with design controls and DHF (Design History File) requirements. This role requires a combination of hands-on technical expertise and strategic vision to guide the team toward innovative solutions.

Key Responsibilities:
- Architect and reengineer software solutions to meet critical product requirements.
- Ensure compliance with design controls and DHF documentation processes.
- Provide technical guidance to teams, drive robust designs, and lead code reviews.
- Develop small Proof of Concepts (PoCs) to validate ideas and demonstrate feasibility.
- Hands-on development in **C#, .NET**, and **MS SQL Server**.
- Collaborate with cross-functional teams on firmware integration and hardware interactions.
- Provide innovative solutions while maintaining high-quality standards for medical device software.

Qualifications:
- Bachelor's or Master's degree in Computer Science, Engineering, or related field.
- Proven experience in software architecture and reengineering, ideally in the medical device or biotech industry.
- Hands-on expertise in **C#, .NET**, and **MS SQL Server**.
- Experience with firmware development; hardware knowledge is a strong plus.
- Thorough understanding of **design controls** and **regulatory compliance** in medical devices.
- Strong analytical, problem-solving, and leadership skills.
- Ability to work onsite in Hercules, CA, 5 days a week.