Test System Software Engineer

This role involves supporting the sustainment and improvement of test systems, automated equipment, and supporting software used in the manufacturing of FDA-regulated medical devices for respiratory therapy. The engineer will focus on software development, systems support, troubleshooting, and ensuring compliance within regulated environments., * Develop, maintain, and optimize test and automation software using LabVIEW, NI TestStand, and Python.

• Write efficient and scalable code in Python for backend testing, data processing, and hardware/software integration.
• Design and implement software solutions that interface with sensors, industrial PCs, DAQ modules, and automated machinery.
• Assist in developing test frameworks, scripts, and utilities used for software/system validation.
• Debug complex code and system behavior across Windows 11, industrial PCs, and embedded device interfaces.
• Diagnose and resolve issues in complex test and measurement systems, including hardware/software interactions and system-level faults.
• Support enterprise IT systems used for device commissioning, access control, configuration management, and backup/recovery processes.
• Perform root cause analysis (RCA) on system failures and implement corrective and preventive actions (CAPA).
• Partner with electrical and mechanical engineering teams to investigate complex system behaviors involving hardware-software integration.
• Analyze ambiguous or intermittent production test issues and develop diagnostic routines to identify hidden failure modes.
• Contribute to the creation of advanced test strategies that correlate data across mechanical, electrical, and software subsystems.
• Work within FDA 21 CFR Part 820.72 and GMP quality system requirements, ensuring data integrity, cybersecurity protections, audit trails, and access controls are properly implemented.
• Maintain clear, compliant documentation of code, workflows, and validation processes.
• Participate in risk analysis and support validation/verification activities for test equipment and software tools.
• Collaborate with cross-functional teams including manufacturing engineering, quality, IT security, and R&D, translating production and engineering needs into technical requirements.
• Train users and provide engineering support for manufacturing personnel and test technicians.

• Bachelor’s degree in computer engineering, software engineering, electrical engineering, or related field.
• Strong proficiency in:
• LabVIEW
• Python
• High-level languages (C++, Java) and associated development environments
• Scripting languages for automation/test development
• Experience working with:
• Windows 11 OS and PC hardware architectures
• Industrial PCs and automated test hardware
• GitHub, source control, debuggers, build systems
• TestStand or similar automated test frameworks
• Debugging complex embedded or computerized systems
• Understanding of the software development lifecycle (SDLC)
• Root cause analysis, fault isolation, and system troubleshooting
• Cybersecurity fundamentals related to access control, data protection, system administration, and networked test systems

Preferred Qualifications

• Prior experience in a medical device or other FDA-regulated industry
• Knowledge of data integrity requirements, ALCOA/ALCOA+ principles, and digital recordkeeping compliance
• Experience validating software or equipment under GxP frameworks
• Background in test equipment calibration, test method validation, or automated manufacturing tools