Job Title
Computer / Software Engineer (Medical Device)
Requisition
Location
Madison, WI
Additional Locations
Job Description Summary
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.
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.
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