Lead Principal Software Engineer - Medical Devices

Job Title: Lead Principal Software Engineer

Location: Remote (US); preferred location: South Florida

Job Type: Full-Time

Reports To: Director of Engineering

Company Description

MedWatch Technologies, Inc. is an early-stage smart wearable company focused on intelligent tools to help people proactively manage their health. The company’s flagship product is a glucose tracking system to improve metabolic health. The technology will expand rapidly to include other key bio-sensing capabilities. The company mission is to empower individuals to proactively take control of their health by providing real-time data on the impact of diet and exercise on metrics that reduce the risk of diabetes and other chronic conditions.

Role Description

We are seeking 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 both independently and as part of a multidisciplinary team.

Key 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

Minimum Education:

• 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 roles involving AI/ML, cybersecurity, or cloud-based medical data management.

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 framework.

·        Expertise with communication protocols like Bluetooth Low Energy (BLE), Wi-Fi, or NFC a must.

·        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 full product lifecycle development.

·        Strong documentation skills for Design History Files (DHF), Risk Management, and Software Development Lifecycle (SDLC) compliance.

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!