{"id":2667650,"url":"https://alion.io/job/compliance360-computer-software-engineer-medical-device","title":"Computer / Software Engineer (Medical Device)","company":{"id":2887687,"name":"Compliance360","domain":"compliance360.com","url":"https://alion.io/company/compliance360","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":75,"open_postings":3,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-16T05:45:00Z"}},"role":"Backend","role_family":"Backend","seniority":null,"employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Madison, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":107000,"max_usd":225000,"period":"year","method":"role_country_seniority_unknown","sample_n":8485},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"C++","optional":false},{"name":"CAPA","optional":false},{"name":"GitHub","optional":false},{"name":"Java","optional":false},{"name":"Python","optional":false},{"name":"Windows","optional":false}],"status":"live","first_seen_at":"2026-08-27T00:00:00Z","employer_posted_date":"2026-08-27","last_verified_at":"2026-10-16T09:01:54Z","board_verified":true,"closed_at":null,"days_open":50,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":50},"description":"Job Title\nComputer / Software Engineer (Medical Device) Requisition\nJR000015837 Computer / Software Engineer (Medical Device) (Open)Location\nMadison, WIAdditional Locations\n Job Description Summary\nWe 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.\nJob Description\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.\nContributes 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.\nEnsures 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:LabVIEW\nPython\nHigh-level languages (C++, Java) and associated development environments\nScripting languages for automation/test development\n\nExperience working with:Windows 11 OS and PC hardware architectures\nIndustrial PCs and automated test hardware\nGitHub, source control, debuggers, build systems\nTestStand or similar automated test frameworks\n\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:Access control\nData protection\nSystem administration\nNetworked test systems\n\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\nOrganizational Relationship/Scope:\nThis 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.\nThis 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.\nWorking Conditions:\nThis 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.\nThe position requires engagement with both development and production settings to diagnose issues, validate design and process changes, and support ongoing product lifecycle needs.\nDomestic and international travel of up to 20% may be required to support manufacturing sites, suppliers, and field issue investigations.\nKeenova 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\nDisclaimer: 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.\nAt 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.\nWe 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.\nWe are Keenova-keen to solve, keen to serve. Learn more at www.keenova.com.","description_format":"text","description_chars":7467,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health & Medical Electronics","Information Security"],"lifecycle":[{"event":"open","at":"2026-10-16T03:14:10Z"}],"visa":[],"liveness":{"score":12,"band":"cold","label":"Long shot","p_open":1,"p_active":0.345,"p_room":0.35,"age_days":50,"expected_fill_days":20,"reasons":["conf:2","win:tail"],"computed_at":"2026-10-16T05:45:00Z"},"pay":null,"html_url":"https://alion.io/job/compliance360-computer-software-engineer-medical-device","json_url":"https://alion.io/job/compliance360-computer-software-engineer-medical-device.json","meta":{"generated_at":"2026-10-16T22:27:52Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":4095,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-17T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":2887687},"rest":"https://alion.io/mcp/rest/get_company?id=2887687"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcompliance360-computer-software-engineer-medical-device"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fcompliance360-computer-software-engineer-medical-device"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fcompliance360-computer-software-engineer-medical-device"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/compliance360-computer-software-engineer-medical-device\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcompliance360-computer-software-engineer-medical-device"}]}