Principal Manufacturing Software Engineer

Overview

Key Skills: Manufacturing Process, PostgreSQL database, Labview

Roles and Responsibilities:

• Design and implement manufacturing software platforms for instrument production workflows including test sequencing, calibration, firmware flashing, and final system verification using Python, C#, and relevant automation frameworks
• Develop and maintain automated test applications interfacing with diagnostic instruments and fixtures to execute and validate production procedures across multiple hardware configurations
• Build secure, compliant data systems for electronic Device History Records (eDHR) ensuring traceability, auditability, and alignment with regulatory requirements
• Lead software validation activities for manufacturing systems in accordance with GAMP 5 and FDA software validation guidelines, including protocol development, execution, and documentation
• Develop service and diagnostic software tools enabling field engineers to perform instrument troubleshooting, repair, and re-certification in alignment with post-market support requirements

Skills Required:

• Minimum 10 years of software development experience.
• Demonstrated expertise in developing manufacturing test systems, hardware-in-the-loop simulation, or test automation frameworks
• Proficiency in object-oriented programming using Python or C#, with a portfolio of production-grade applications
• Hands-on experience designing software that interfaces with physical hardware and test equipment in production or lab environments
• Industry experience in regulated sectors such as diagnostics, medical devices, aerospace, or automotive, including database design and SQL-based data management for production systems

It would be a plus if you also possess previous experience in:

• Direct experience developing software under a diagnostic/ medical device quality management system (ISO 13485)
• Familiarity with the requirements for software validation in an FDA-regulated environment
• Experience with National Instruments hardware and software (LabVIEW, TestStand)
• Knowledge of industrial communication protocols (CAN, Modbus, TCP/IP, etc.)

Education:Bachelor's or Master's degree in Computer Science, Computer Engineering, or a related field