DevOps Engineer – Medical Devices (f/m/x)
⚲ Warszawa, Lublin, Kraków, Gdańsk, Katowice, Łódź, Poznań, Rzeszów, Szczecin, Białystok
Do uzgodnienia
Wymagania
- SonarQube
- Bitbucket
- YAML
- IEC 62304
- CI/CD
- Jenkins
- SOP Development
- AzureDevOps
- Git
Opis stanowiska
We are looking for an experienced DevOps Engineer to join a project delivered for a company in the medical technology industry, developing software for medical devices in a strictly regulated environment.
This is a role for a specialist who wants to have a real impact on the quality and safety of solutions used in the healthcare sector.
Your tasks
• Designing, implementing, and maintaining automated CI/CD pipelines for medical device software in Azure DevOps or equivalent environments
• Building and maintaining pipeline-as-code solutions using YAML and integrating automated testing and analysis tools
• Ensuring CI/CD workflows comply with SOPs and regulatory requirements, including traceability, auditability, and reproducibility
• Integrating tools such as VectorCAST, SonarQube, Black Duck, and unit testing frameworks into CI/CD processes
• Collaborating with Software Engineering, QA, and Compliance teams to ensure regulatory alignment and product quality
• Supporting change control processes and contributing to audit readiness and DHF-compliant documentation
Requirements
• Minimum 5 years of experience in DevOps/CI/CD engineering, preferably in regulated or safety-critical environments
• Hands-on experience with medical device software development standards (e.g., IEC 62304, ISO 13485, or equivalent)
• Strong experience with CI/CD tools (preferably Azure DevOps) and pipeline-as-code (YAML)
• Proficiency in Git-based workflows, branching strategies, and distributed version control systems
• Knowledge of DevSecOps practices, including IAM, secrets management, and secure CI/CD design
• Very good understanding of regulatory frameworks (FDA 21 CFR Part 820, EU MDR) and change control processes
• Fluent English, both written and spoken
• Fluent Polish required
• Residing in Poland required
This is a role for a specialist who wants to have a real impact on the quality and safety of solutions used in the healthcare sector.
Your tasks
• Designing, implementing, and maintaining automated CI/CD pipelines for medical device software in Azure DevOps or equivalent environments
• Building and maintaining pipeline-as-code solutions using YAML and integrating automated testing and analysis tools
• Ensuring CI/CD workflows comply with SOPs and regulatory requirements, including traceability, auditability, and reproducibility
• Integrating tools such as VectorCAST, SonarQube, Black Duck, and unit testing frameworks into CI/CD processes
• Collaborating with Software Engineering, QA, and Compliance teams to ensure regulatory alignment and product quality
• Supporting change control processes and contributing to audit readiness and DHF-compliant documentation
Requirements
• Minimum 5 years of experience in DevOps/CI/CD engineering, preferably in regulated or safety-critical environments
• Hands-on experience with medical device software development standards (e.g., IEC 62304, ISO 13485, or equivalent)
• Strong experience with CI/CD tools (preferably Azure DevOps) and pipeline-as-code (YAML)
• Proficiency in Git-based workflows, branching strategies, and distributed version control systems
• Knowledge of DevSecOps practices, including IAM, secrets management, and secure CI/CD design
• Very good understanding of regulatory frameworks (FDA 21 CFR Part 820, EU MDR) and change control processes
• Fluent English, both written and spoken
• Fluent Polish required
• Residing in Poland required
🔍 Dekoder Ogłoszenia
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This is a role for a specialist who wants to have a real impact on the quality and safety of solutions used in the healthcare sector.
Może to oznaczać, że praca będzie wymagała dużej odpowiedzialności i skrupulatności, a błędy mogą mieć poważne konsekwencje, co przekłada się na stres i presję.
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Ensuring CI/CD workflows comply with SOPs and regulatory requirements, including traceability, auditability, and reproducibility
Praca będzie ściśle związana z dokumentacją i procesami zgodności, co może oznaczać znacznie więcej czasu poświęcanego na formalności niż na czyste kodowanie czy automatyzację.
🔴
Supporting change control processes and contributing to audit readiness and DHF-compliant documentation
Oczekuje się aktywnego udziału w procesach zarządzania zmianą i przygotowywania dokumentacji na potrzeby audytów, co może być czasochłonne i wymagać precyzji.
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preferably in regulated or safety-critical environments
Chociaż jest to preferencja, sugeruje, że doświadczenie w takich środowiskach jest bardzo pożądane i może być kluczowe dla kandydata.