{"schemaVersion":"jobsearcher.job.v1","id":"ed069ff5ae187f8293c8a771","url":"https://jobsearcher.com/jobs/ed069ff5ae187f8293c8a771","canonicalUrl":"https://jobsearcher.com/jobs/ed069ff5ae187f8293c8a771","title":"Computer Engineer","description":"Job Title: Computer Engineer - Sustaining Engineering, Medical Devices\nJob Location: Madison, WI\nJob Description:\nWe are seeking an experienced Computer 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.\nThe 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.\nKey Responsibilities:\nSoftware Development & Test System Engineering\nDevelop, maintain, and optimize test and automation software using LabVIEW, NI TestStand, and Python.\nWrite efficient and scalable code in Python for backend testing, data processing, and hardware/software integration.\nDesign and implement software solutions that interface with sensors, industrial PCs, DAQ modules, and automated machinery.\nAssist in developing test frameworks, scripts, and utilities used for software/system validation.\nDebug complex code and system behavior across Windows 11, industrial PCs, and embedded device interfaces.\nSystems Support & Troubleshooting\nDiagnosing and resolving issues in complex test and measurement systems, including hardware/software interactions and system-level faults.\nSupport enterprise IT systems used for device commissioning, access control, configuration management, and backup/recovery processes.\nPerform root cause analysis (RCA) on system failures and implement corrective and preventive actions (CAPA).\nCross-Disciplinary Engineering Support\nPartner with Electrical and Mechanical Engineering teams to investigate complex system behaviors involving hardware–software integration.\nAnalyze ambiguous or intermittent production test issues where failures present in subtle, non-obvious ways to users or operators.\nDevelop software tools, instrumentation scripts, and diagnostic routines to capture hidden failure modes that traditional hardware diagnostics may not detect.\nContribute to the creation of advanced test strategies that correlate data across mechanical, electrical, and software subsystems.\nRegulatory & Compliance Responsibilities\nWork within FDA 21 CFR Part 820.72 and applicable GMP quality system requirements.\nEnsure data integrity, cybersecurity protections, audit trails, and access controls are properly implemented in test systems.\nMaintain clear, compliant documentation of code, workflows, and validation processes.\nParticipate in risk analysis and support validation/verification activities for test equipment and software tools.\nCollaboration & Technical Leadership\nCollaborate with cross-functional teams including Manufacturing Engineering, Quality, IT Security, and R&D.\nTranslate production and engineering needs into technical requirements for software and test systems.\nTrain users and provide engineering support for manufacturing personnel and test technicians.\nRequired Qualifications:\nBachelor’s degree in Computer Engineering, Software Engineering, Electrical Engineering, or related field.\nStrong proficiency in:\nLabVIEW\nPython\nHigh-level languages (C++, Java) and associated development environments\nScripting languages for automation/test development\nExperience working with:\nWindows 11 OS and PC hardware architectures\nIndustrial PCs and automated test hardware\nGitHub, source control, debuggers, build systems\nTestStand or similar automated test frameworks\nHands-on experience debugging complex embedded or computerized systems.\nUnderstanding of the software development lifecycle (SDLC).\nExperience with root cause analysis, fault isolation, and system troubleshooting.\nFamiliarity with cybersecurity fundamentals related to:\nAccess control\nData protection\nSystem administration\nNetworked test systems\nPreferred Qualifications:\nPrior experience in a medical device or other FDA-regulated industry.\nKnowledge of data integrity requirements, ALCOA/ALCOA+ principles, and digital recordkeeping compliance.\nExperience validating software or equipment under GxP frameworks.\nBackground in test equipment calibration, test method validation, or automated manufacturing tools\nSoft Skills:\nStrong communication and documentation abilities.\nDetail-oriented with a disciplined approach to working within regulated processes.\nAbility to manage multiple tasks, prioritize effectively, and collaborate across diverse teams.\nProblem-solving mindset with a focus on system reliability and continuous improvement.\nPay: $65.00 - $75.00 per hour\nApplication Question(s):\nHow many years of experience do you have, supporting sustaining engineering in a manufacturing environment?\nDo you have experience with LabVIEW and NI TestStand?\nHave you used Python in an engineering or manufacturing environment?\nHow many years of experience do you have with debugging hardware and software integration issues?\nWill you now, or in the future, require sponsorship for employment visa status (e.g. H-1B visa status)?\nWork Location: In person","company":"Stellar It Solutions","rawCompany":"stellar it solutions","city":"Madison","state":"WI","isRemote":false,"isActive":false,"createdAt":"2026-08-03T22:52:45.264Z","occupations":[{"code":"15-1299.08","title":"Computer Systems Engineers/Architects","slug":"computer-systems-engineers-architects"},{"code":"15-1252.00","title":"Software Developers","slug":"software-developers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"334111","title":"Electronic Computer Manufacturing","slug":"electronic-computer-manufacturing"},{"code":"541512","title":"Computer Systems Design Services","slug":"computer-systems-design-services"},{"code":"541715","title":"Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)","slug":"research-and-development-in-the-physical-engineering-and-life-sciences-except-nanotechnology-and-biotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Computer Engineer","description":"Job Title: Computer Engineer - Sustaining Engineering, Medical Devices\nJob Location: Madison, WI\nJob Description:\nWe are seeking an experienced Computer 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.\nThe 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.\nKey Responsibilities:\nSoftware Development & Test System Engineering\nDevelop, maintain, and optimize test and automation software using LabVIEW, NI TestStand, and Python.\nWrite efficient and scalable code in Python for backend testing, data processing, and hardware/software integration.\nDesign and implement software solutions that interface with sensors, industrial PCs, DAQ modules, and automated machinery.\nAssist in developing test frameworks, scripts, and utilities used for software/system validation.\nDebug complex code and system behavior across Windows 11, industrial PCs, and embedded device interfaces.\nSystems Support & Troubleshooting\nDiagnosing and resolving issues in complex test and measurement systems, including hardware/software interactions and system-level faults.\nSupport enterprise IT systems used for device commissioning, access control, configuration management, and backup/recovery processes.\nPerform root cause analysis (RCA) on system failures and implement corrective and preventive actions (CAPA).\nCross-Disciplinary Engineering Support\nPartner with Electrical and Mechanical Engineering teams to investigate complex system behaviors involving hardware–software integration.\nAnalyze ambiguous or intermittent production test issues where failures present in subtle, non-obvious ways to users or operators.\nDevelop software tools, instrumentation scripts, and diagnostic routines to capture hidden failure modes that traditional hardware diagnostics may not detect.\nContribute to the creation of advanced test strategies that correlate data across mechanical, electrical, and software subsystems.\nRegulatory & Compliance Responsibilities\nWork within FDA 21 CFR Part 820.72 and applicable GMP quality system requirements.\nEnsure data integrity, cybersecurity protections, audit trails, and access controls are properly implemented in test systems.\nMaintain clear, compliant documentation of code, workflows, and validation processes.\nParticipate in risk analysis and support validation/verification activities for test equipment and software tools.\nCollaboration & Technical Leadership\nCollaborate with cross-functional teams including Manufacturing Engineering, Quality, IT Security, and R&D.\nTranslate production and engineering needs into technical requirements for software and test systems.\nTrain users and provide engineering support for manufacturing personnel and test technicians.\nRequired Qualifications:\nBachelor’s degree in Computer Engineering, Software Engineering, Electrical Engineering, or related field.\nStrong proficiency in:\nLabVIEW\nPython\nHigh-level languages (C++, Java) and associated development environments\nScripting languages for automation/test development\nExperience working with:\nWindows 11 OS and PC hardware architectures\nIndustrial PCs and automated test hardware\nGitHub, source control, debuggers, build systems\nTestStand or similar automated test frameworks\nHands-on experience debugging complex embedded or computerized systems.\nUnderstanding of the software development lifecycle (SDLC).\nExperience with root cause analysis, fault isolation, and system troubleshooting.\nFamiliarity with cybersecurity fundamentals related to:\nAccess control\nData protection\nSystem administration\nNetworked test systems\nPreferred Qualifications:\nPrior experience in a medical device or other FDA-regulated industry.\nKnowledge of data integrity requirements, ALCOA/ALCOA+ principles, and digital recordkeeping compliance.\nExperience validating software or equipment under GxP frameworks.\nBackground in test equipment calibration, test method validation, or automated manufacturing tools\nSoft Skills:\nStrong communication and documentation abilities.\nDetail-oriented with a disciplined approach to working within regulated processes.\nAbility to manage multiple tasks, prioritize effectively, and collaborate across diverse teams.\nProblem-solving mindset with a focus on system reliability and continuous improvement.\nPay: $65.00 - $75.00 per hour\nApplication Question(s):\nHow many years of experience do you have, supporting sustaining engineering in a manufacturing environment?\nDo you have experience with LabVIEW and NI TestStand?\nHave you used Python in an engineering or manufacturing environment?\nHow many years of experience do you have with debugging hardware and software integration issues?\nWill you now, or in the future, require sponsorship for employment visa status (e.g. H-1B visa status)?\nWork Location: In person","datePosted":"2026-08-03T22:52:45.264Z","dateModified":"2026-08-03T22:52:45.264Z","hiringOrganization":{"@type":"Organization","name":"Stellar It Solutions","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Madison","addressRegion":"WI","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"ed069ff5ae187f8293c8a771"},"url":"https://jobsearcher.com/jobs/ed069ff5ae187f8293c8a771"}}