Software Engineer – Quality Applications (Java)

Work Arrangement: Hybrid – 3 days per week onsite.

Position Purpose The Software Engineer, Quality Applications is responsible for the development, enhancement, validation, and support of applications built in-house or a vendor-provided platform. Hands-on experience leveraging AI tools is desired.

This role partners closely with Quality, Regulatory, laboratory operations, infrastructure, and business stakeholders to keep these applications reliable, compliant, and effective in supporting the organization’s regulatory and operational needs, while contributing to their ongoing technical modernization.

Principal Accountabilities

• Proven experience designing, developing, and supporting enterprise applications using Java, Python, Oracle Database, SQL/PLSQL, and web technologies, with the ability to maintain and modernize complex legacy and business-critical systems.
• Hands-on experience developing and supporting business rules engines, system integrations, automated workflows, reporting solutions, and data analytics platforms, including Power BI and enterprise reporting tools.
• Demonstrated ability to support regulated operational environments by delivering high-quality software solutions, troubleshooting production issues, optimizing system performance, and collaborating with cross-functional business and technical stakeholders.
• Extensive experience in software development, testing, validation, and deployment of enterprise applications (CI/CD), ensuring quality, reliability, and compliance with organizational standards and regulatory requirements.
• Proven ability to provide application support and operational maintenance, including incident management, root cause analysis, performance monitoring, and continuous improvement of production systems.
• Strong background in application modernization, automation, and technical debt reduction, leveraging scripting, cloud technologies, and modern development practices to improve efficiency and scalability.
• Experience developing and maintaining technical documentation, system procedures, reporting solutions, and knowledge repositories to support ongoing operations and knowledge transfer.
• Demonstrated success collaborating with cross-functional business, quality, regulatory, operations, and technology teams to deliver solutions that meet business objectives, compliance expectations, and operational needs.

Position Requirements

Education

• Bachelor’s degree in Computer Science, Information Systems, Engineering, or related field; equivalent experience considered.

Required Skills & Experience

• 6 years of software engineering or application development experience, including experience supporting production enterprise applications.
• Hands-on experience with Java, Tomcat, Python, Spring Boot Framework.
• Strong SQL and Oracle database skills, including query development, performance tuning, and troubleshooting.
• Experience supporting or developing web-based applications and working with legacy runtime environments while contributing to modernization efforts.
• Experience working within a regulated GxP or GAMP-based software development lifecycle, including computer system validation practices.
• Strong analytical, debugging, and problem-solving skills, with the ability to work effectively with Quality, Regulatory, and business stakeholders.

Required AI Skills

• Hands-on use of enterprise-approved AI-assisted development tools, such as GitHub Copilot, Microsoft Copilot, or equivalent.
• Ability to apply AI to code generation and review, debugging, test creation, documentation, requirements analysis, and solution design.
• Practical understanding of prompt engineering, large language model capabilities and limitations, and responsible AI principles.
• Ability to test and validate AI-generated outputs before use in production or regulated processes.
• Awareness of security, privacy, data protection, intellectual property, traceability, and governance considerations when using AI.

Preferred Skills & Experience

• Awareness of FDA 510(k) requirements, and the ability to support development and documentation practices consistent with medical device regulatory expectations.
• Exposure to healthcare, life sciences, validated systems, or another regulated environment; relevant foundational cloud or developer certification is a plus.

Competencies

• Learning Agility — rapidly builds knowledge of unfamiliar technologies, systems, and business processes.
• Problem Solving — uses a structured approach to investigate issues and seeks guidance when needed.
• Engineering Discipline — produces tested, documented, maintainable work and follows agreed standards.
• Collaboration — works constructively with technical and non-technical colleagues across functions and locations.
• Accountability — owns assigned tasks, communicates progress and risks, and follows through on commitments.
• Customer Focus — understands how reliable technology supports donors, employees, and business operations.
• Quality & Compliance Mindset — treats security, privacy, validation, and auditability as part of solution delivery.
• AI Fluency — uses AI where it helps, evaluates outputs critically, and applies the same quality expectations to AI-assisted work as to other software.