Discover our flagship product: an innovative glucose-tracking wearable device to enhance metabolic health! This cutting-edge device offers rapidly expanding capabilities that include critical bio-sensing features, giving you even more insights into your well-being.
We empower people to take charge of their health! With real-time insights into diet and exercise, we help reduce the risk of diabetes and other chronic conditions.
Role Description
We seek an experienced Principal Software Engineer to lead the development of our backend architecture and mobile applications, ensuring compliance with FDA regulations, ISO 13485, and IEC 62304. This role will be instrumental in designing secure, scalable systems that integrate with our biosensor technology. The ideal candidate has a proven track record of launching medical device software products and can work independently and as part of a multidisciplinary team.
K ey Responsibilities
• Architect, develop and maintain a secure and scalable backend infrastructure for a medical device ecosystem.
• Design and implement mobile applications that interface with wearable biosensors via Bluetooth or other wireless protocols.
• Ensure compliance with FDA regulations, ISO 13485, IEC 62304, HIPAA, and cybersecurity best practices.
• Lead software development efforts, including coding, testing, and documentation, ensuring high reliability and quality.
• Collaborate with firmware, hardware, and regulatory teams to align software with system requirements.
• Define and execute software verification and validation in accordance with regulatory standards.
• Work with cloud-based technologies for data management, security, and analytics.
• Provide technical leadership, mentor junior engineers, and manage software development processes.
Education & Experience Requirements
• Bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, Electrical Engineering, or a related field.
Preferred Education:
• Master’s degree in a relevant field, particularly for AI/ML, cybersecurity, or cloud-based medical data management roles.
Skills/Qualifications
• 10+ years of software development experience, with at least 5 years in medical devices.
• Expertise in backend development (e.g., Python, Node.js, Java, or C#) and cloud platforms (AWS, Azure, or Google Cloud).
• Experience with mobile application development (iOS and Android) using Flutter, Dart, or similar cross-platform frameworks.
• Expertise with communication protocols like Bluetooth Low Energy (BLE), Wi-Fi, or NFC is essential. Lead Principal Software Engineer - Medical Devices
• Deep understanding of medical software regulations, including IEC 62304, ISO 13485, FDA 21 CFR Part 820, HIPAA, and cybersecurity frameworks.
• Experience developing secure, scalable, and FDA-compliant cloud solutions.
• Strong background in DevOps, CI/CD pipelines, and test automation for regulated environments.
• Experience with data privacy, encryption, and secure API development.
• Ability to work independently and lead a team through product lifecycle development.
• Strong documentation skills for compliance with Design History Files (DHF), Risk Management, and Lifecycle (SDLC) Software Development.
Preferred Qualifications
• Experience with AI/ML in healthcare applications.
• Knowledge of wireless communication security and cybersecurity risk management (ISO 27001, NIST 800-53, OWASP, etc.).
• Familiarity with FHIR, HL7, or other healthcare interoperability standards.
Why Join Us?
• Opportunity to lead and shape software architecture in an innovative medical device company.
• Work with a talented, cross-functional team in a high-growth startup environment.
• Competitive compensation, equity options, and comprehensive benefits.
• Ability to impact the future of wearable medical technology.
• If you are passionate about developing world-class software in a medical device environment, we’d love to hear from you!
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