Principle DevOps Engineer (Medical Devices & Embedded Systems)

Job Title: Principal DevOps Engineer Medical Devices & Embedded Systems

Location: Waltham, MA

Duration: Long-term

Job Description:

We are looking for an experienced Principal DevOps Engineer to design, maintain, and automate CI/CD infrastructure for embedded systems and medical device software. The candidate will work closely with engineering and regulatory teams to ensure automated software builds, code quality checks, security integration, and compliance with medical device regulatory standards.

Key Responsibilities:

• Design, develop, optimize, and manage CI/CD pipelines and developer toolchains.
• Configure and automate software and firmware builds for embedded systems and target hardware.
• Integrate and maintain static code analysis tools, linters, and automated testing suites within CI/CD pipelines.
• Implement security practices, threat modeling, and DevSecOps tools within deployment workflows.
• Ensure build tools, environments, and pipeline components comply with medical device software validation requirements.
• Execute approved validation plans and prepare technical validation reports for regulatory audits.
• Automate build and development tasks using scripting languages.
• Collaborate with engineering and regulatory teams to improve software quality and compliance.

Required Skills:

• Strong experience with CI/CD tools such as Jenkins, GitLab CI, GitHub Actions, or Azure DevOps.
• Hands-on experience with embedded software or firmware build environments.
• Experience with build automation tools such as CMake, Make, Docker, GCC, and Clang.
• Experience integrating static code analysis tools such as SonarQube, Coverity, Klocwork, or Cppcheck.
• Familiarity with DevSecOps tools such as Black Duck SCA, Artifactory, and GitHub Enterprise.
• Proficiency in Python, Bash, or PowerShell scripting.
• Understanding of security practices and threat modeling.
• Familiarity with medical device regulatory standards such as ISO 13485, IEC 62304, and FDA 21 CFR Part 11.
• Experience with software tool validation processes and technical validation documentation.