Senior DevOps & Release Engineer
About The Position
As a Senior DevOps & Release Engineer, you will join a multidisciplinary engineering organization responsible for delivering regulated Software as a Medical Device (SaMD) solutions. You will work closely with Software Engineering, Quality Assurance, Regulatory Affairs, Security, IT, Product, and Research teams to ensure the delivery of secure, reliable, compliant, and audit-ready software platforms used in clinical and field environments. The primary operational environment for this role consists of Linux-based physical devices, workstations, and on-premise systems used for software development, validation, testing, and clinical deployment. You will be responsible for ensuring these systems are reproducible, maintainable, secure, and operationally reliable throughout the software lifecycle. This role serves as the technical authority for Linux operational infrastructure, DevOps, CI/CD, build and release engineering, software deployment, and system automation within a regulated medical device environment. While AWS and Azure are used for selected supporting services and workloads, cloud infrastructure is not the primary focus of the role.
Requirements
- 6+ years of experience in DevOps, Release Engineering, or System Engineering
- Deep Linux administration, preferably Debian/Ubuntu environments
- Bare-metal/ /on-premise systems experience
- Programming: Python, Bash, C++
- Strong understanding of system security, networking, deployment architectures, and operational best practices
- Experience with GitHub administration, CI/CD tooling, Jira, and source control governance
- Hands-on experience with Jenkins, TeamCity, or similar CI platforms
- Experience supporting GPU-enabled systems and native application build environments
- Experience with AWS and Azure cloud ecosystems
Nice To Haves
- Experience in C++, QT-based applications
- Experience working in regulated industries such as medical devices, healthcare, or life sciences
- Familiarity with IEC 62304, ISO 13485, and ISO 14971 standards
- Experience supporting validation activities, audits, inspections, and compliance evidence generation
- Prior experience supporting Software as a Medical Device (SaMD) products
- Experience with ML/AI deployment workflows in regulated environments
- Experience designing DevOps systems intended for regulatory evidence and audit readiness
Responsibilities
- Design, implement, and maintain secure and reproducible DevOps infrastructure supporting Linux-based medical software and hardware.
- Own the end-to-end software build, packaging, release, deployment, and operational lifecycle while ensuring compliance with FDA, ISO 13485, IEC 62304, and ISO 14971 expectations.
- Contribute to operational excellence by implementing scalable automation, secure deployment mechanisms, validated CI/CD systems, and traceable release processes suitable for regulated environments and audit readiness.
- Administer Debian Linux systems.
- Support Linux-based deployment and security on bare-metal devices (not cloud).
- Design, maintain, and evolve DevOps and release engineering platforms.
- Ensure reliability, reproducibility, and operational consistency across development, validation, testing, and production systems.
- Align operational practices with risk management and post-market surveillance activities.
- Own software build, packaging, release, rollback, and patch management processes.
- Support controlled software release strategies consistent with regulated medical environments.
- Design and maintain CI/CD pipelines supporting regulated software development workflows.
- Administer and optimize tooling including GitHub, Jenkins, TeamCity, or equivalent systems.
- Automate build generation, testing, static analysis, packaging, and artifact management.
- Ensure CI/CD outputs are auditable and suitable as objective evidence during inspections and audits.
- Ensure infrastructure and DevOps practices comply with the field norms such as IEC 62304, ISO 13485, ISO 14971, and FDA cybersecurity guidance.
- Implement defense-in-depth security controls across build systems, deployment pipelines, and operational environments.
- Enforce least-privilege access, authentication controls, secure secrets management, and audit logging.
- Support internal audits, FDA inspections, and ISO certification activities through proper documentation and evidence generation.
- Support lifecycle management of ML/AI inference components within regulated environments.
- Ensure model versioning, traceability, controlled promotion, and alignment with released software versions.
- Maintain reproducible ML build environments and containerized workflows where appropriate.
- Implement monitoring, logging, and operational observability for on-premise clinical systems and development environments.
- Support incident response, root cause investigations, CAPAs, and continuous improvement initiatives.
- Maintain operational records and deployment logs supporting audit and compliance requirements.
- Act as the primary technical authority for DevOps and release engineering practices.
- Mentor junior DevOps and platform engineers.
- Translate regulatory and quality requirements into practical, scalable technical implementations.
- Maintain clear operational documentation, deployment procedures, rollback guides, and technical runbooks.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
