V&V Systems Engineer

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 Verification and Validation Systems Engineer for regular position.
The Verification and Validation Systems Engineer is responsible for the verification and validation for Radiometer Product Systems in medium/high-complexity design projects. You will be applying system engineering knowledge and head verification and validation of systems solutions within technical, schedule and cost constraints. You will be part of systems engineering team with specialists in chemistry, blood testing, laboratory activities, requirements engineering, risk management, integration and verification.
This position is part of the Product Verification team located in Copenhagen, Denmark and will be hybrid position. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.
You will report to the R&D Associate Director, Blood Gas Product Verification responsible for verification and validation of systems and product systems. If you thrive in a regulatory environment, defining strategy, working in a cross functional role and want to build world-class engineering solutions for point-of-care (POC) testing —read on.

THE ESSENTIAL REQUIREMENTS OF THE JOB INCLUDE:

• Master’s degree or equivalent in chemistry, biochemistry or biophysics
• Experience planning verification activities according to GLP within complex electronic and/or software systems
• Experience in Medical Device/In-vitro Diagnostics standards and regulations (IVDR, MDR, CLSI etc.)
• Ability to communicate, positively influence and negotiate at all levels within an organization
• Mastery in spoken and written English

• Defining, managing and deploying the verification and validation strategy for Radiometer product systems (incl. estimating realistic timelines and budgets)
• Participating in system verification activities in a cross functional environment (R&D, QAE, RA etc.)
• Identifying process improvements and developing best practices (incl. QMS processes)
• Supporting verification and validation of medical devices according to relevant guidelines (i.e. documentation and data analysis for sensitivity, linearity, precision, interference studies, and stability studies)
• Validating tools used during product design and development