Sustaining Engineer – Computer / Software

Mallinckrodt Pharmaceuticals•Madison, WI

5d•Onsite

About The Position

We are seeking an experienced Computer / Software Engineer to support the Sustaining Engineering team responsible for maintaining and improving test systems, automated equipment, and supporting software used in the manufacture of FDA regulated medical devices for respiratory therapy. This role focuses on test and support systems not directly embedded in the therapeutic device, but which are essential for product verification, production workflows, and device commissioning. The ideal candidate has strong software engineering skills, hands-on experience with automated test systems, and deep familiarity with regulated environments (FDA 21 CFR Part 820.72, GMP). They will ensure test system reliability, maintain compliance, support cybersecurity controls, and drive continuous improvement across manufacturing support technologies.

Requirements

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
Hands-on experience debugging complex embedded or computerized systems.
Understanding of the software development lifecycle (SDLC).
Experience with root cause analysis, fault isolation, and system troubleshooting.
Familiarity with cybersecurity fundamentals related to: Access control
Data protection
System administration
Networked test systems

Nice To Haves

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
Strong communication and documentation abilities.
Detail-oriented with a disciplined approach to working within regulated processes.
Ability to manage multiple tasks, prioritize effectively, and collaborate across diverse teams.
Problem-solving mindset with a focus on system reliability and continuous improvement.

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.
Diagnosing and resolving 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 where failures present in subtle, non-obvious ways to users or operators.
Develop software tools, instrumentation scripts, and diagnostic routines to capture hidden failure modes that traditional hardware diagnostics may not detect.
Contributes 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 applicable GMP quality system requirements.
Ensures data integrity, cybersecurity protections, audit trails, and access controls are properly implemented in test systems.
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.
Translate production and engineering needs into technical requirements for software and test systems.
Train users and provide engineering support for manufacturing personnel and test technicians.