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Sustaining Engineer - Computer / Software

Mallinckrodt

Madison, WI

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JOB DETAILS
SKILLS
Access Control, Analysis Skills, Automation Systems, C++ Programming Language, Calibration, Clinical Laboratory, Code of Federal Regulations, Commission Controls, Commissioning, Communication Skills, Computer Engineering, Computer Security, Computer Software, Configuration Management, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Critical Care, Cross-Functional, Data Processing, Data Quality, Data Recovery, Debugging Skills, Debugging Tools, Detail Oriented, Documentation, Electrical Engineering, Electricity, Embedded Systems, Endocrinology, Engineering, Establish Priorities, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), GitHub, GxP, Hardware Architecture, Hardware Quality Assurance, Hardware-Software Integration, Healthcare, Identify Issues, Immunology, Information Technology & Information Systems, Information/Data Security (InfoSec), Instrumentation, Internet Security, Java, LabVIEW Programming Language, Maintain Compliance, Manufacturing, Manufacturing Engineering, Manufacturing Technology, Manufacturing/Production Testing, Materials Management, Mechanical Engineering, Medical Equipment, Microsoft Windows Operating System, Multitasking, Network Systems, Network Testing, Orthopedics, PC Hardware, Patient Care, Pediatrics, People Management, Performance Management, Problem Solving Skills, Process Improvement, Product Lifecycle, Product Support, Product Testing, Product/Service Launch, Python Programming/Scripting Language, Quality Assurance Methodology, Reliability Testing, Research & Development (R&D), Respiratory Therapy, Risk Analysis, Root Cause Analysis, Scripting (Scripting Languages), Software Administration, Software Design, Software Development, Software Development Lifecycle (SDLC), Software Engineering, Software Testing, Software Validation, Source Code/Configuration Management (SCM), Strategic Planning, Surveillance, System Validation, Systems Administration/Management, Systems Engineering, Systems Reliability, Technical Leadership, Technical Support, Test Automation, Test Data, Test Equipment, Test Harness, Test Plan/Schedule, Test Scripts, Test Strategy, TestStand, Testing, Tool and Die Manufacturing, Urology, Use Cases, Validation Testing, Willing to Travel
LOCATION
Madison, WI
POSTED
Today
Job Title
Sustaining Engineer - Computer / Software

Requisition

JR000015837 Sustaining Engineer - Computer / Software (Open)

Location

Madison, WI

Additional Locations

Job Description Summary
We are seeking anexperienced 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.

Job Description

Key Responsibilities:

Software Development & Test System Engineering
  • 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.
Systems Support & Troubleshooting
  • 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).
Cross-Disciplinary Engineering Support
  • 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.
Regulatory & Compliance Responsibilities
  • 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.
Collaboration & Technical Leadership
  • 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.
Required 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
  • 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
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
Soft Skills:
  • 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


Organizational Relationship/Scope:

This position operates cross-functionally and collaborates regularly with Product Performance, Complaint Management, Service Support, Device Quality, Post-Market Surveillance, Device Development, and Materials Management, as well as external partners, to address product lifecycle challenges and support new product introductions.

This is an advanced role requiring deep technical understanding of products and therapy across multiple use cases, along with the ability to interpret and balance stakeholder needs. The position serves as a key technical resource, providing guidance, influencing decisions, and driving alignment across functions to ensure effective resolution of complex product issues.

Working Conditions:

This role operates across a range of environments, including office, engineering laboratory, and medical device manufacturing areas, supporting hands-on investigation, testing, and product support activities.

The position requires engagement with both development and production settings to diagnose issues, validate design and process changes, and support ongoing product lifecycle needs.

Domestic and international travel of up to 20% may be required to support manufacturing sites, suppliers, and field issue investigations.

Keenova offers employees a Total Rewards package which includes competitive pay and benefits. To learn more about our Total Rewards benefits please visit: Keenova Careers | Serve and Grow with Purpose | Keenova

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

#LI-GN1

At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support-showing up in big moments and small to help patients find comfort and confidence.

We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men's health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.

We are Keenova-keen to solve, keen to serve. Learn more at www.keenova.com.

About the Company

M

Mallinckrodt