Job Description

As a Principal Software Engineer in the medical device sector, you will lead the design, development, and validation of cutting-edge software solutions that power life-enhancing technologies. You will serve as a technical authority, guiding architecture decisions, ensuring compliance with regulatory standards (such as FDA, ISO, and IEC), and driving innovation in embedded systems, cloud platforms, or mobile applications used in clinical and patient-facing environments.

In this role, you will collaborate closely with cross-functional teams including systems engineering, quality assurance, regulatory affairs, and clinical experts to deliver safe, reliable, and effective software. You will mentor engineers, champion best practices in software development, and contribute to strategic product planning. Your work will directly impact patient outcomes, making technical excellence and attention to detail critical.

ROLES AND RESPONSIBILITIES

• Lead medical product software development process that is compliant to IEC 62304.
• Act as the lead software engineer building framework tools for embedded and mobile applications.
• Experience in interfacing to wi-fi modules and cell modems in phone or custom embedded applications.
• Build and use standardized software development processes, tools, and methodologies that elevate code quality, operational consistency, and overall project profitability.
• Experience building and implementing tools and automation processes, driving efficiency and reducing development and if applicable operational costs
• Collaborate with team to build UI/UX design and usability process development to IEC 62366-1.
• Develop and lead the implementation of software quality assurance principles and methods.
• Ensure cybersecurity requirements for medical devices and mobile applications are met including IEC 81001-5-1 or FDA Cybersecurity Guidance for Premarket Submissions.
• Select and utilize various analytic tools to optimize software performance.

MINIMUM EXPERIENCE AND EDUCATION REQUIREMENTS

• Minimum of 10 years of experience developing FDA/IEC regulated software.
• Minimum of 5 years leading and building mobile applications.
• Previous experience dealing with EHR integration and HIPPA compliance preferred.
• Relevant software development and medical device experience required. Advanced degree preferred.
• Proven experience in one or more of the software development methodologies as a team leader: Agile, Scrum, Test-Driven Development (TDD), Continuous Integration/Continuous Deployment (CI/CD).
• Proficient in Linux including custom driver or hardware abstraction layer development to devices requiring I2C, SPI, USB, RS-232, and CSI/MIPI interfaces.
• Proven experience with two or more of the following programming Languages: C++, C#, Objective-C, Swift, Java, Flutter, Kotlin, assembly language, etc.
• General understanding in three or more of the different phone app frameworks: Core Data, Location, & Animation, Apple Human Interface Guidelines, RESTful APIs, Cocoa Touch, AVFoundation, UIKit, JSON, Native Android, NativeScript SDK, jQuery Mobile, React Native.
• Proficient interfacing with one or more databases: Realm, MongoDB, Core Data, MSSQL, and MySQL, SQLite, Firebase, Cassandra.
• Knowledge in digital image processing and analysis to derive quantitative and qualitative assessments is preferred.
• Knowledge of machine learnings to develop AI models is preferred.
• Proven ability to work independently to meet goals using exceptional time management skills, prioritization, and execution within a dynamic environment.
• Demonstrated business acumen with the proven ability to work independently as well as collaboratively in a cross-functional team environment.
• Early stage/start up experience strongly preferred.

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