Full-Stack Software Engineer – In Vitro Diagnostics (IVD) & Biological Analysis

About the role

The Software Engineer leads full-stack software development for medical In Vitro Diagnostic (IVD) devices and provides software engineering support for biological analysis software packages. This role bridges low-level hardware interaction and high-level user interfaces, developing robust software applications, configuring operating system environments, and verifying code against established regulatory and technical specifications. The engineer will design and build intuitive UI/UX for non-technical users to control complex scientific instruments, interface directly with microcontrollers and embedded hardware, and enable automated analysis of complex biological datasets to provide actionable information to end users.

Responsibilities

• Lead full-stack software development efforts for medical IVD systems and biological analysis software, spanning lower-level microcontroller/hardware interfaces to upper-level application logic and user interfaces.
• Design, build, and refine intuitive graphical user interfaces (UI/UX) that enable scientific personnel and non-technical operators to control analytical instruments and sensor networks.
• Program, integrate, and test low-level microcontrollers (e.g., Arduino or similar platforms) to communicate with biological sensors, custom boards, and peripherals.
• Write, test, and optimize high-performance C++ codebases as well as Python applications for instrumentation control, data processing, and analytical workflows.
• Implement cybersecurity controls, software hardening procedures, and secure coding practices within production and operational environments.
• Adhere to quality management system (QMS) protocols and regulatory/ISO standards (e.g., ISO 13485, ISO 62304) throughout the software development lifecycle, including formal design controls, risk assessments, and code documentation.
• Collaborate with cross-functional teams—including biologists, systems engineers, hardware developers, and project leads—to translate technical wireframes and scientific requirements into production-ready software.
• Troubleshoot and debug complex hardware/software integration issues, recreating user workflows to isolate root causes and optimize operating efficiency.
• Author and maintain software lifecycle documentation, design specifications, verification/validation protocols, and end-user operating manuals.

Requirements

• BS in Computer Science, Computer Engineering, Electrical Engineering with a software focus, or equivalent technical degree.
• 3 to 5 years of professional software engineering experience.
• Prior experience in medical devices (IVD), biotechnology, or scientific analytical instrumentation software development is strongly preferred.
• This position requires that the candidate be willing and able to complete a successful background screening for a security clearance. Candidates with a current security clearance will receive preference.

Skills

• C++ Expertise: Strong software development experience in modern C++ for application and hardware-adjacent logic.
• Microcontrollers & Hardware Interfacing: Demonstrated experience working with microcontrollers (e.g., Arduino, ARM, or microprocessors) and hardware communication protocols.
• UI/UX Design: Proven ability to create user-centered, intuitive GUIs and desktop/embedded interface experiences.
• Python (Highly Preferred): Proficiency in Python for scripting, backend application logic, data science pipelines, or test automation.
• Full-Stack Development: Solid understanding of full-stack system architecture, connecting frontend user interfaces through backend processing to low-level device drivers and hardware.
• ISO & Regulatory Compliance (Preferred): Familiarity or prior experience working within ISO quality frameworks (e.g., ISO 13485, ISO 62304, ISO 9001, or equivalent regulated industry standards, with med-tech experience strongly preferred).
• Cybersecurity (Preferred): Knowledge of cybersecurity controls, system security procedures, secure boot/data handling, and vulnerability mitigation in production software.
• Production Environments: Experience building, deploying, and maintaining software in commercial production environments.
• Operating Systems & Tools: Experience with Linux environments, custom board configurations, version control (Git