Lab Automation Software Engineer – Medical Devices

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.

• Develop software that interfaces with mechanical and electrical systems, primarily liquid handling instruments
• Create software integrations for larger systems involving data management and sample tracking
• Design and implement robust automation solutions for high-throughput laboratory environments within FDA-regulated medical device settings
• Collaborate with cross-functional teams to translate manual wet-lab processes into scalable automated workflows
• Design 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 reports
• Participate in all phases of the software development lifecycle
• Create and maintain technical documentation under FDA design controls (21 CFR 820.30)
• Translate product and quality requirements into software specifications
• Contribute to software system architecture and document designs using UML or similar methodologies
• Maintain, troubleshoot, optimize, and debug existing software systems
• Develop software applications and associated unit tests
• Execute module, unit, and system-level testing to ensure compliance with regulatory, quality, and product requirements
• Generate technical content for software user guides and service manuals
• Develop internal software tools to improve data analysis and management workflows
• Troubleshoot issues spanning software, electrical, and mechanical systems
• Mentor junior engineers and interns while supporting development of engineering best practices
• Support Quality Management System policies and procedures
• Collaborate effectively across technical and non-technical teams

• Bachelor’s degree in Engineering, Computer Science, or a related field
• 3+ years of relevant industry experience
• Experience developing software for automated systems, laboratory equipment, or medical devices
• Understanding of software development lifecycle processes within regulated environments
• Familiarity with FDA design controls and quality systems for medical devices
• Strong technical writing and documentation skills
• Experience developing software interfaces for mechanical and electrical systems
• Ability to troubleshoot complex systems across software, hardware, and instrumentation domains
• Experience with liquid handling instruments, especially Hamilton  instruments, is preferred
• Experience contributing to successful software launches from concept through customer release is preferred
• Strong communication and collaboration skills
• Ability to work independently and within cross-functional teams
• New graduates with relevant internship, academic, or project experience are encouraged to apply

Carex 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.

#LI-WR1