Software Architect

Suntra MedTech Solutions; Bedford (NH); On-site; USD 140,000 - 210,000; Full time

Job summary

Suntra MedTech Solutions is seeking a senior software architect for medical device software to lead high-level design and drive architectural decisions in Bedford, NH. The role requires close collaboration with project managers and software teams on multiple device projects.

You will oversee risk management, cybersecurity, and regulatory compliance (IEC 62304) while guiding engineering teams and shaping development processes across programs.

Qualifications

• Bachelor’s degree in software engineering, CS, or EE with 10+ years of industry experience.
• Proficiency in C, C++, C#, and JavaScript; embedded systems experience.
• Familiarity with Agile/Scrum processes and regulatory standards.

Responsibilities

• Architecture & design of scalable, secure medical device software.
• Collaborate with project managers and software teams; provide architectural guidance.
• Conduct code reviews; enforce coding standards and maintainability.

Skills

Embedded systems

Programming in C/C++/C#/JavaScript

Agile/Scrum

Regulatory compliance knowledge

Technical leadership

Education

Bachelor’s degree in software engineering/CS/EE

Master’s degree preferred

Tools

Atlassian tools (Jira/Confluence)

CI/CD pipelines

Linux OS

Job description

Job Type

Full-time

Position Overview:

Responsible for the high-level architecture and design of medical device software, ensuring alignment with system and software requirements. This “hands-on” role requires you to be in our Bedford, NH office (on a scheduled basis) to collaborate with project managers and software teams on multiple projects. The role includes reviewing detailed designs, the testing structure, and code, while also focusing on risk management and cybersecurity to ensure device safety for users and clinicians. It also offers the chance to lead technical initiatives, guide engineering teams, and make a significant impact on the development of medical devices.

Key Responsibilities

• Architecture & Design: Develop scalable, secure, and compliant software architecture based on system and software requirements.
• Collaboration & Leadership: Work closely with project managers and software teams, providing architectural guidance and mentoring engineers.
• Code Quality & Reviews: Conduct code reviews, enforce coding standards, and ensure high-quality, maintainable code.
• Regulatory Compliance: Ensure adherence to regulatory standards (e.g., IEC 62304) for medical device software.
• Risk Management & Cybersecurity: Integrate safety measures and conduct risk assessments to ensure device safety.
• Continuous Improvement: Advocate for best practices, evaluate new technologies, and enhance development processes.

Qualifications

• Required: Bachelor’s degree in software engineering, Computer Science, Electrical Engineering, or a related field; 10+ years of industry experience; proficiency in programming languages (e.g., C, C#, C++, JavaScript); experience with embedded systems, and medical device development; familiarity with Agile/Scrum processes.
• Beneficial: Master’s degree; experience in Class B and C medical devices; Linux OS configuration; familiarity with test-driven development (TDD), CI/CD, and regulatory standards like IEC 62304.
• Preferred: Experience using generative AI to aid in software development, developing machine learning-based products, knowledge of embedded Linux, real-time operating systems (RTOS), and cybersecurity hardening, as well as familiarity with Atlassian tools and software development best practices.