Senior Manager Software Engineering

The Senior Manager of Software Engineering will be responsible for overseeing the software development lifecycle across mobile, cloud, and embedded platforms in support of our medical device portfolio, ensuring the delivery of robust and scalable software solutions. This individual will drive the development of patient-facing applications, device connectivity (Wi-Fi/Bluetooth), and backend systems, while ensuring adherence to regulatory standards, including FDA and ISO requirements. This role requires a strategic thinker with a strong technical background and excellent leadership skills to manage and mentor a team of engineers.

• Lead and mentor a multi-disciplinary software team (mobile, embedded, cloud) in a regulated environment, providing guidance, mentorship, and performance feedback.
• Develop and implement software engineering strategies, goals, and objectives aligned with company vision.
• Manage the end-to-end software development lifecycle across iOS, Android, embedded firmware, and cloud-based services.
• Oversee the development of patient-facing applications used for device configuration, data sync, remote monitoring, and product support.
• Architect and guide integration between mobile apps and medical devices via Bluetooth (BLE) and Wi-Fi.
• Define and enforce software development best practices, including CI/CD, cybersecurity, documentation, and risk management.
• Collaborate with Software Verification, Regulatory, Marketing, Clinical, and Operations teams to ensure software meets product design and FDA regulatory requirements and international standards (IEC 62304, ISO 13485).
• Ensure adherence to best practices in software development, including coding standards, testing, and documentation.
• Monitor and improve software development processes to enhance efficiency and quality.
• Stay current with evolving mobile OS requirements, cloud architectures (Azure/AWS), and medical device connectivity protocols.
• Drive sprint planning, resource allocation, and project tracking using Agile methodologies.
• Foster a culture of continuous improvement, collaboration, and innovation within the engineering team.
• Other duties as assigned

Education & Experience:

Required:

• Bachelor's in Computer Science, Software Engineering, or a related field.
• 8+ years of software development experience, including 3+ years in a leadership role.
• Familiarity with mobile development frameworks (e.g., React Native, Swift, Kotlin), cloud-native apps (Azure), and embedded platforms (e.g., FreeRTOS, STM32, Zephyr).
• Experience working with cloud services (Azure preferred), containerization (Docker/Kubernetes), and modern development stacks.
• Hands-on experience designing and implementing mobile solutions to target both iOS and Android mobile platforms from development to market, with experience in medical device software development
• Hands-on experience with one or more of the following programming languages: .net, Java, Python, Swift, C/C++
• In-depth experience and proven track record of designing and implementing digital health solutions and risked-based SaMD according to ISO 13485
• Exceptional problem-solving and decision-making abilities.
• Knowledge of data privacy, security, and HIPAA requirements.
• Excellent leadership and team management skills, with a track record of building and leading high-performing teams, utilizing agile methodologies and software development lifecycle management.
• Strong communication and interpersonal skills, with the ability to collaborate effectively with stakeholders at all levels.

Preferred:

• Experience with remote patient monitoring or digital therapeutics
• Familiarity with tools such as Jira, Azure DevOps, GitHub Actions, or Jenkins.
• Prior involvement in regulatory submissions or audits (510(k), CE Mark, etc.).
• Expertise with Bluetooth Low Energy (BLE) and Wi-Fi device connectivity.
• Cloud solution architect certificate (e.g., AWS Solution Architect Associate or Azure AZ-304)
• Advanced degree and additional related certifications

Knowledge & Skills:

• Particularly adept at effective communication with app developers, user designers, data engineers, system architects and firmware teams but also equally adept at communicating with those with a non-technical background
• Strong ownership with a leadership mindset, able to adapt and thrive in ambiguous or uncertain environments
• Ability to set strategy and follow through on tactical implementation and execution of initiatives
• Proven success developing product roadmaps, requirements and user experiences
• Demonstrated ability to lead business initiatives to a successful result, using resources effectively and efficiently
• Self-directed, internally motivated and driven
• Strong analytical skills and attention to detail required, including a thorough understanding of how to interpret customer business needs and translate them into application and operational requirements
• Ability to reconcile key stakeholder interests, conflicting priorities, and business strategy and influence without formal management authority