Test System Software Engineer

Talascend is currently seeking a Test System Software Engineer for a contract opportunity with our client in Madison, Wisconsin.

Overview

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.

Responsibilities

• 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.

Qualifications

• 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

There are no specified shift requirements for this remote position.