Software Quality Engineer

Summary

Join Promaton, a remote-first startup revolutionizing global dental healthcare, as a Software Quality Engineer. You will play a crucial role in ensuring the quality and regulatory compliance of our medical device software. Responsibilities include reviewing requirements, developing test plans, executing tests, analyzing results, and collaborating with cross-functional teams. This position requires a degree in a relevant field, hands-on experience in medical device software development, and knowledge of relevant regulatory standards. Promaton offers excellent employment terms, remote work flexibility, professional development opportunities, and a strong company culture.

Requirements

• A degree in computer science, engineering, medical technology or related field
• Hands-on experience in software medical device development projects, in accordance with IEC 62304, IEC 82304, AAMI TIR 45, IEC 62366, IEC 81001-5-1
• Knowledge of regulatory requirements for medical devices including EU MDR, ISO 13485 and ISO 14971
• Interest in emerging trends on artificial intelligence within medical technology (EU AI Act, FDA AI & Machine Learning guidelines)
• You are fluent in English, have great written communication skills and are able to clearly articulate your vision and decision-making process while working within a highly collaborative, cross-functional team
• Experience with the Python programming language
• Some CI/CD experience or exposure (eg. Jenkins, Github Actions)
• Based in Europe, in a time zone between UTC-1 and UTC+3 (-2/+2 hours Amsterdam time) and willing to join our company events 4 times a year

Responsibilities

• Reviewing user and software requirements, actively engaging with product and development teams to seek clarification and improve specifications
• Outlining the goals of the internal testing process, choosing the appropriate testing techniques, developing test plans and protocols
• Coordinating execution and executing planned tests (both manual and automated tests), analyzing test results
• Providing detailed information about defects or deviations from specifications
• Ensuring the whole process meets regulatory compliance standards, including maintaining up-to-date technical documentation
• Collaborate in troubleshooting product issues and risk management activities to enhance product quality
• Interact with customers/partners to follow their testing requirements and processes, supporting the design transfer from development to production
• Contribute to the validation of internal software systems (non-device software tools)

Preferred Qualifications

• Experience with Cloud based applications (eg. AWS, Azure)
• Basic understanding or interest in AI/ML

Benefits

• Excellent employment terms
• Freedom to work from anywhere (and any time you like). We are a remote-first company by design with people from all over Europe
• Dedicated time for hackathons and research to explore new ideas of your own
• Training budget for books, online courses, conferences, or anything else you need to grow
• Work with cutting-edge technology at the forefront of rapidly evolving medical innovation
• Loads of responsibility, autonomy and a chance to make a real impact
• Awesome yearly company retreat and quarterly team events
• Competitive annual leave package that varies by location
• Top-notch gear
• Promaton is funded for many years to come, meaning you can have the impact you only get at a startup but with the job security of an established company
• For international candidates: Join us from anywhere through Remote.com in your local country, or become part of our Dutch team, where we are a recognized visa sponsor!