Engineer II, Systems Software

W2 only, no C2C, must be authorized to work in the US (both now and in the future).Engineer II, Systems Software (Direct Hire) - in Madison, Wisconsin. Apply now for this opportunity at Carex!Carex is partnering with a biotech industry partner to hire an Engineer II, Systems Software. This role is responsible for designing, developing, and testing medical device software that supports automated systems and laboratory equipment in high-throughput clinical lab environments. The Engineer II will collaborate closely with scientists and cross-functional teams to automate wet-lab processes, develop scalable software solutions, and support products that directly impact patient care. This position plays a key role across the software development lifecycle, including supporting FDA regulations, design controls, testing, and documentation.What You'll DoDevelop software that interfaces with mechanical and electrical systems, primarily liquid handling instrumentsCreate software integrations for larger systems involving data management and sample trackingDesign and implement robust automation solutions for high-throughput laboratory environments within FDA-regulated medical device settingsCollaborate with cross-functional teams to translate manual wet-lab processes into scalable automated workflowsDesign and execute experiments evaluating software controls on mechanical systems and document findings following good documentation practices (GDP)Develop experimental protocols, formal test plans, and detailed reportsParticipate in all phases of the software development lifecycleCreate and maintain technical documentation under FDA design controls (21 CFR 820.30)Translate product and quality requirements into software specificationsContribute to software system architecture and document designs using UML or similar methodologiesMaintain, troubleshoot, optimize, and debug existing software systemsDevelop software applications and associated unit testsExecute module, unit, and system-level testing to ensure compliance with regulatory, quality, and product requirementsGenerate technical content for software user guides and service manualsDevelop internal software tools to improve data analysis and management workflowsTroubleshoot issues spanning software, electrical, and mechanical systemsMentor junior engineers and interns while supporting development of engineering best practicesSupport Quality Management System policies and proceduresCollaborate effectively across technical and non-technical teamsWhat You'll BringBachelor’s degree in Engineering, Computer Science, or a related field3+ years of relevant industry experienceExperience developing software for automated systems, laboratory equipment, or medical devicesUnderstanding of software development lifecycle processes within regulated environmentsFamiliarity with FDA design controls and quality systems for medical devicesStrong technical writing and documentation skillsExperience developing software interfaces for mechanical and electrical systemsAbility to troubleshoot complex systems across software, hardware, and instrumentation domainsExperience with liquid handling instruments, especially Hamilton ML_STAR instruments, is preferredExperience contributing to successful software launches from concept through customer release is preferredStrong communication and collaboration skillsAbility to work independently and within cross-functional teamsNew graduates with relevant internship, academic, or project experience are encouraged to applyCarex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity, or Veteran status.