Principal Software Engineer

Company Description

Digital Health Solutions is a Boston-based engineering and regulatory consulting firm specializing in end-to-end product development and contract manufacturing for medical devices and Med Tech products. With teams in Boston and India, the company supports clients across hardware, electronics, firmware, mobile applications, and IoT/cloud components, as well as verification, validation, and regulatory services. The organization is experienced in product ideation, design and development, re-engineering, testing, sustainment engineering, and full regulatory submissions.

Core competencies include connected device design, adherence to IEC 62304, ISO 13485, ISO 14971, FDA cybersecurity guidance, UX and human factors, and scalable contract manufacturing. Team members collaborate in a multidisciplinary environment where engineering excellence and regulatory rigor drive faster, safer product launches.

• Architect, Design, develop, and maintain cloud-based applications, services and APIs using C#/.NET and Azure
• Lead technical design reviews, establish architecture patterns, and enforce best practices across the stack.
• Collaborate with product management and engineering teams to translate business requirements into scalable, reliable system designs.
• Provide accurate work-effort estimates and technical risk assessments for new features and system enhancements.
• Define and implement Infrastructure as Code (IaC) and manage CI/CD pipelines for automated, repeatable deployments.
• Guide the selection and adoption of emerging technologies and AI-assisted development tools to enhance team productivity.
• Build and support React-based frontends for clinician and patient-facing applications
• Work closely with firmware, systems, QA, and regulatory teams to ensure software meets medical device quality and compliance standards
• Participate in code reviews, design discussions, and SDLC documentation including risk control, architecture, and verification support for FDA submissions
• Follow best practices for cybersecurity, authentication, and privacy, aligned with HIPAA and FDA guidance

• Minimum 10 years of professional software engineering experience
• Minimum 5 years of hands‑on experience with cloud development using C#, .NET, React, and Azure
• Minimum 5 years of experience designing software that interacts with hardware or embedded devices.
• Minimum 2 years of experience working in regulated industries such as medical devices, healthcare, or life sciences
• Familiarity with FDA regulations, IEC 62304, or ISO 13485
• Strong understanding of REST APIs, CI/CD pipelines, Git, and cloud security principles
• Strong experience with database management systems, especially PostgreSQL.
• Experience with IoT, firmware communication (Bluetooth, WiFi, Serial), and associated protocols.
• Solid understanding of microservices architecture, event‑driven design patterns, RESTful APIs
• Prior experience in consulting or multi‑client environments

• Experience with Bluetooth Low Energy (BLE) or connected health devices
• Exposure to tools like Jira, Git Hub, Azure Dev Ops, or document automation systems used in FDA submissions
• Experience with Cybersecurity Procedures:
  Vulnerability Assessment, Static Code Analysis, Penetration Testing, etc.

• Competitive salary and benefits package, including health insurance, 401(k) plan with employer match, vision, dental and paid time off.
• Opportunity to work with cutting‑edge technology in the medical device industry.
• A supportive, collaborative work environment that fosters professional growth and development.
• The chance to make a meaningful impact on the safety and effectiveness of medical devices, ultimately improving patients' lives.
• Breadth you will not get at a large device company: multiple concurrent client programs across Class I to III devices, SaMD, and connected health platforms, with hands‑on involvement in FDA submissions.
• Small‑company visibility: direct access to the CEO and senior leadership, and real influence over technical direction and tooling.