Software Engineering Lead overseeing cloud-native platform development for regulated industry. Collaborating with partners to deliver secure, scalable, compliant systems with advanced technologies.
Responsibilities
Lead internal software engineering efforts for a cloud-native platform developed in a regulated environment
Collaborate with external development partners to guide architecture, design, and implementation decisions
Define and enforce technical standards, coding practices, and architectural patterns that support scalability, maintainability, and compliance
Own the design and management of deployment environments (cloud and edge), ensuring high availability, security, and performance
Design, implement, and maintain CI/CD pipelines that support compliant software development and deployment processes
Partner with Quality Assurance and Compliance teams to ensure all software development activities align with applicable regulatory frameworks (e.g., FDA 21 CFR Part 11, GxP)
Participate in code reviews, architecture reviews, and validation planning to ensure traceability, auditability, and data integrity
Contribute to the selection and integration of tools for infrastructure-as-code, monitoring, logging, and automated testing
Mentor internal team members and contribute to building long-term internal engineering capabilities
Requirements
Bachelor’s or Master’s degree in Computer Science, Engineering, or a related field
8 years of experience in software engineering, with at least 3 years in a technical leadership or architecture role
Proven experience building and deploying cloud-native applications, ideally in Microsoft Azure
Experience with AWS or GCP is also valued
Hands-on experience with CI/CD pipelines, containerization (Docker, Kubernetes), and infrastructure-as-code (e.g., Terraform, Bicep, or ARM templates)
Familiarity with edge computing architectures and integrating IoT or AI-enabled devices
Strong understanding of software development in regulated environments, including GxP and FDA 21 CFR Part 11
Experience working with external development partners or distributed teams
Excellent communication and collaboration skills, with the ability to translate between technical and business stakeholders
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