V&V Systems Engineer

âIn our line of work, life isnât a given - itâs 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 weâre located. Creating impactful innovations like ours, doesnât 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, weâre working at the pace of change to improve patient lives with diagnostic tools that address the worldâs 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 âread on.

In this role, you will have the opportunity to:

• 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

The essential requirements of the job include:

• Masterâs 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

It would be a plus if you also possess the following:

• Advanced understanding of MDR, IVDR, ISO 13485, ISO 14971, ISO 62366

• Ability to coach and mentor other Systems Engineers as a Subject Matter Expert.

• Self-starter who drives pro-actively activities which are in own area of responsibility.

• Systems Engineering qualifications (e.g., INCOSE CSEP, ISO 15288) or working towards.

Other

• The candidate should feel comfortable dealing with periods of high demand intensity and high exposure to top management focus

• The candidate will operate in an environment with high compliance and ethical standards

Travel (required estimated % of time)

• App 10-15% of the time

At Radiometer we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Radiometer can provide.

Application

We continuously assess candidates and invite them for interviews, so please donât hesitate to write and send in the application. The recruitment will be completed as soon as suitable candidate is found.

If you have questions, feel free to contact the Hiring manager Anna Bellini, Associate R&D Director, Product Verification by email anna.bellini@Radiometer.dk

We look forward to seeing your application.

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrowâs science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering whatâs next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.