Position Purpose: 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.
Essential Duties and 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.
Required Knowledge, Skills & Abilities:- 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), and issue tracking systems (Jira).
- Analytical & Problem-Solving Skills: Diagnostic and debugging capabilities for complex hardware-software-data integrations.
- Java and other coding languages/frameworks (Optional): Additional familiarity with other languages is a plus.
Education/Experience:- 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..
Clearance:- 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.
Supervisory Responsibilities:Working Conditions / Equipment:- This is a full-time, on-site position with flexible work arrangements. This position primarily operates during standard business hours, with occasional needs for extended workdays or weekend work to meet project timelines. The role may also require infrequent domestic travel for conferences, trade shows, or research-related meetings. The ability to lift and carry light loads (under 25 lbs) without assistance is necessary.
