Director Engineering Medical Device Jobs in Utah

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.

In this role, you will design, implement, and maintain secure and reproducible DevOps infrastructure supporting Linux-based medical software and hardware. You will 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.
You will 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.

DevOps Architecture & Operational Infrastructure
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

Build, Packaging & Release Engineering
Own software build, packaging, release, rollback, and patch management processes
Support controlled software release strategies consistent with regulated medical environments

CI/CD & Automation
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

Validation, Security & Compliance
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

ML/AI Operational Support
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

Monitoring, Incident Response & Operational Excellence
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

Leadership & Collaboration
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

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

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

The position is based onsite in Salt Lake City, USA. You might be required to travel within the USA and France per business needs.