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Digital Health Solutions

Senior Software Engineer - Medical Devices

Digital Health Solutions, Andover, Massachusetts, us, 05544

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Job Title : Senior Software Engineer Medical Devices Location : Andover, MA; Company Overview : At Digital Health Solutions, we specialize in developing and supporting next-generation medical technologies from embedded systems and connected mobile apps to cloud platforms, regulatory strategy, and contract manufacturing. As an ISO 13485-certified partner, we work with innovators building Class IIII medical devices, SaMD, and connected digital health solutions. We are looking for a Senior Software Engineer to support our growing portfolio of medical device software projects. This is a hands-on role for someone who enjoys building secure, scalable systems across both cloud and mobile platforms and is comfortable working within a regulated product development environment. Responsibilities : Design, develop, and maintain cloud-based services and APIs using C#/.NET and Azure Build and support React-based frontends for clinician and patient-facing applications Develop and maintain native Android applications in Java, integrating with BLE-connected medical devices and cloud services 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 Required Qualifications : Minimum 5 years of professional software engineering experience Minimum 3 years of hands-on experience with cloud development using C#, .NET, React, and Azure Minimum 2 years of experience developing native Android apps in Java Experience working in regulated industries such as medical devices, healthcare, or life sciences Strong understanding of REST APIs, CI/CD pipelines, Git, and cloud security principles Nice to Have Familiarity with FDA regulations, IEC 62304, or ISO 13485 Experience with Bluetooth Low Energy (BLE) or connected health devices Exposure to tools like Jira, GitHub, Azure DevOps, or document automation systems used in FDA submissions Prior experience in consulting or multi-client environments What We Offer : 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.