Computer / Software Engineer (Medical Device)

Mallinckrodt Pharmaceuticals; Alabama; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Total Rewards package

Job summary

Keenova in Madison, WI seeks an experienced Computer/Software Engineer to support Sustaining Engineering for test systems and manufacturing software in FDA-regulated environments. You will develop and maintain LabVIEW, Python, and C++ code, interface with sensors and automation hardware, and ensure data integrity and cybersecurity across test platforms.

The role requires hands-on experience with automated test rigs, strong SDLC knowledge, and collaboration with cross-functional teams to drive

Qualifications

• Bachelor’s degree in Computer/Software/Electrical Engineering or related field.
• Strong proficiency in LabVIEW, Python, high-level languages (C++, Java) and automation scripting.
• Experience with Windows11, industrial PCs, automated test hardware, version control, and TestStand or similar.
• Familiarity with SDLC, root cause analysis, and system troubleshooting.

Responsibilities

• Develop, maintain, and optimize test and automation software.
• Design software interfaces with sensors, industrial PCs, and DAQ modules.
• Support debugging and validation of test systems and software tools.
• Collaborate with cross-functional teams to ensure compliance and reliability.

Skills

Python

C++

Java

Scripting languages

Education

Bachelor’s degree in Computer Engineering, Software Engineering, Electrical Engineering, or related field

Tools

LabVIEW

NI TestStand

GitHub

Windows11

Job description

Job Title

Computer / Software Engineer (Medical Device)

Location

Madison, WI

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.

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 Windows11, 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: Windows11 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 improvement.

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.

Benefits

• Competitive pay and benefits as part of Keenova Total Rewards package.

Company Culture

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.

About Keenova

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. At Keenova, we know that we contribute to something that matters because we make quality products that impact patient lives.

Career Growth

Our dynamic work environment provides unique experiences for employees to grow and develop. Invest in your own career with Keenova and let’s do something dynamic together.

Equality and Inclusion

Keenova provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law. Additional information on Keenova’s hiring practices may be found by clicking.