Systems Engineer with FDA experience (maternity cover)

at  Radiometer

In our line of work, life isn’t a given - it’s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we’re located. Creating impactful innovations like ours, doesn’t happen overnight - it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career.
Radiometer is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.
We are looking for a Systems Engineer in Immunoassay R&D within Acute Care Diagnostics in a maternity cover till end of 2024. We focus on engineering solutions for point-of-care (POC) testing. Our products enable caregivers working in acute care to make critical diagnostics decisions fast.
Our product AQT90 FLEX offers a range of biomarkers, that cover myocardial infarction, heart failure, infection, venous thromboembolism, and pregnancy. In acute care situations, when time matters most, AQT90 FLEX analyzer delivers reliable quantitative results, supporting timely diagnosis and workflow efficiency. AQT90 FLEX is state of the art in vitro diagnostic product (IVD) that combines chemistry, mechanics, electronics, and software ability to provide best patient outcomes. Intrigued?
The position is situated in Copenhagen, Denmark. You will be actively working with R&D teams in Denmark, Finland & India. In this role, you will be responsible for applying system knowledge, systems engineering processes and skills to develop systems solutions within technical, schedule and cost constraints. You will be part of systems engineering team with specialists in chemistry, requirements engineering, usability engineering, risk management, integration, and verification. As a part of the job, you will work in close collaboration with designers within assay, mechanics, electronics, and software design.
We have an informal and creative atmosphere where respect is pivotal, and we thrive for the common goal. We work with a problem-solving perspective with an attention to details and focus on quality. Our work ensures that the quality standards are met through documentation.
Your new perspectives, insights and ideas are the cornerstones of our success, and we encourage you to think out of the box and structure your workflow with a high degree of freedom. If you have built your experience on the same vision as us, we would like to meet you!

THE ESSENTIAL REQUIREMENTS OF THE JOB INCLUDE:

• Master’s degree in Engineering
• Experience in Medical Device/In Vitro Diagnostic standards and regulations (IVDR, MDR, CLSI, etc.) and working in accordance with GLP
• Experience with system verification documentation for regulatory submissions
• Experience working with statistical study design and data analysis
• Fluency in written and spoken English

• Create data analysis and evaluate system verification studies
• Trouble shoot and problem solve
• Establish documentation for FDA clearances and CE mark
• Be involved in project management activities (stakeholder management, estimate realistic timelines, drive activities)