Senior QA Técnico validating complex solutions for Stefanini focused on real - time data flows and APIs. Collaborating in Scrum methodology ensuring quality across teams in a hybrid work environment.
About the role
- Senior Software Design QA Engineer ensuring software medical device products meet regulatory and quality standards. Leveraging AI-driven tools and automation while maintaining compliance standards in a hybrid work environment.
Responsibilities
- Implement and maintain design control processes for software medical devices, ensuring compliance with IEC 62304, IEC 82304, ISO 13485, EU MDR, and FDA requirements.
- Lead risk management activities for software and AI/ML technologies in accordance with ISO 14971.
- Define and execute verification and validation strategies for software medical devices, including AI/ML validation and automated testing frameworks.
- Create and maintain audit-ready technical documentation including Software Design History Files (DHFs), risk files, and SOUP management.
- Plan, facilitate, and document design reviews ensuring designs meet safety, performance, usability, and cybersecurity requirements.
- Drive software design transfer activities, working with DevOps and Operations teams for smooth transition to production.
- Ensure DevOps-integrated quality gates and continuous compliance monitoring across CI/CD pipelines.
- Act as a subject matter expert for audits and inspections related to software design quality and cloud/ SaaS compliance.
- Develop scripts, automation, and AI-driven tools to streamline documentation, testing, and compliance workflows.
Requirements
- 5+ years of experience in Software Design Quality Engineering within the medical device industry.
- BSc or MSc in computer science, software engineering, biomedical engineering, or equivalent technical discipline.
- Strong knowledge of IEC 62304, IEC 82304, ISO 14971, ISO 13485, and EU MDR/FDA requirements for software medical devices.
- Hands-on experience with design controls, risk management, and verification & validation for software systems.
- Understanding of DevOps practices, CI/CD pipelines, and automated testing frameworks.
- Engineering mindset with experience in modern QA tooling, test automation, and AI-driven solutions.
- Proficient in scripting languages (Python, PowerShell) or eager to develop these skills.
- Strong communicator who thrives in cross-functional collaboration with software engineers and DevOps teams.
- Excellent written and verbal communication skills in English.
Benefits
- Why Join Us? At Neko Health, you'll work in an innovative and collaborative environment, shaping the future of AI/ML driven and cloud-native medical technologies while ensuring regulatory compliance and efficient design transfer. • We offer a dynamic work environment with a high degree of autonomy that fosters growth and development.
- Please note: we perform background and reference checks as part of our interview process.
Job title
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