Associate Principal Test Software Engineer

Position Summary & Responsibilities:

This role is based in St Louis with an onsite requirement and cannot be remote.

The Instrument Tech Transfer team develops new equipment, procedures, and test software for IVD medical device products that deliver rapid, high-impact, actionable results in immunoassays, microbiology, and molecular biology. The Senior Software Engineer will play a critical role in developing and supporting software that directly impacts patient health and consumer product safety. This role requires a blend of embedded system experience, desktop application development, and software architecture design, all within a regulated environment. Key technologies used in this role include, but are not limited to: C#, SQL, Python, WPF, .NET MAUI, USB, CAN, and other various communication protocols. 

This role is ideal for a software engineer who has experience at the intersection of embedded systems and desktop application development, understands the nuances of regulated software design, and is eager to contribute to an evolving software development environment.

• Software Development: Write, test, and maintain high-quality C# code for software applications, ensuring compliance with quality and regulatory requirements.
• Design and Architecture: Collaborate with cross-functional teams to design software solutions and system architecture, emphasizing flexibility and maintainability over performance optimization to accommodate evolving regulatory requirements and ensure long-term adaptability.
• Embedded System Interaction: Work closely with the R&D Firmware Engineering team to understand and interact with embedded systems using USB, CAN, and serial communication protocols.
• Device Connectivity: Develop software that interfaces with external devices, ensuring robust communication and data handling.
• Regulatory Compliance: Design software with FDA, QSR, and ISO quality system regulations in mind, ensuring adherence to 21 CFR Part 11 requirements.
• Software Release & Deployment: Develop and manage software release processes, considering desktop software installation challenges, including network-based deployments.
• Technical Leadership: Establish software development best practices, set up Jira workflows, and introduce process improvements tailored to an evolving software environment, such as implementing code review guidelines, refining CI/CD pipelines, and optimizing software validation processes to enhance efficiency and compliance.
• Documentation & Design Standards: Create and maintain accurate design documents that align with the actual software implementation, ensuring traceability and compliance with quality standards.
• Testing & Debugging: Develop unit tests, integration tests, and performance tests to validate software functionality, ensuring robustness and reliability.
• Version Control & Collaboration: Utilize Git and participate in code reviews to maintain high-quality code standards and knowledge sharing within the team.
• Risk Assessment & Mitigation: Identify and grade potential risks and failure modes in software design and implementation. Develop mitigation and control methods to prevent failures and ensure system reliability.

Education, Skills, & Experience:

• A Bachelor's degree in Computer Science, Software Engineering, or related field with 4 years of software development experience OR Master's degree in Computer Science, Software Engineering, or related field with 2 years of software development experience
  • High School Diploma/GED with 8 years of software development experience OR
  • Associates degree or professional certification with 6 years of software development experience
• Programming Skills: Proficiency in C# for desktop application development, SQL, Python, WPF, and .NET MAUI (nice to have).
• Embedded Systems: Understanding of USB, CAN, and serial communication protocols for interacting with firmware and embedded devices.
• Software Development Best Practices: Experience with structured software development methodologies (Agile, Scrum) and maintaining software quality within a regulated environment.
• Technical Leadership: Ability to establish software workflows, introduce new tools, and drive process improvements in a growing software team.
• System Design for Compliance: Experience designing software with regulatory constraints in mind, focusing on modularity and minimizing non-product software validation (NPSV) regression risks, which involve unintentional changes in validated software components that can require extensive re-validation efforts.
• Desktop Software Deployment: Familiarity with unique challenges of deploying desktop applications, particularly in network-based environments.
• Problem-Solving Skills: Strong analytical and troubleshooting abilities to resolve complex software development challenges.
• Collaboration & Communication: Effective at working with cross-functional teams, including product managers, QA engineers, and firmware developers.
• Adaptability: Willingness to learn and apply new technologies and software design approaches to meet project needs.

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