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.

　　The Product Systems Verification and Validation Lead is responsible for the verification and validation strategy for the immunoassay product portfolio and deploying the verification and validation testing for low and high complexity 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, requirements engineering, usability engineering, risk management, integration, and verification.

　　This position is part of the Systems Integration & 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 Manager, Systems Integration & Verification responsible for integration, 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.

　　In this role, you will have the opportunity to:

　　Defining, managing and deploying the verification and validation strategy for the immunoassay systems (incl. estimating realistic timelines and budgets)

　　Identifying process improvements and developing best practices (incl. QMS processes)

　　Leading system verification activities in a cross functional environment (R&D, QAE, RA etc.)

　　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:

　　Master’s degree or equivalent in chemistry, biochemistry, biophysics or electronics

　　Experience leading and 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.)

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

　　Ability to communicate, positively influence and negotiate at all levels within an organization using English as the company language.

　　It would be a plus if you also possess previous experience in:

　　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.

　　A hybrid way of working:At Radiometer we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid 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 for interviews, so please don’t hesitate to submit your CV/resume and cover letter. We encourage you to apply before February 1st, 2024. If you have questions, feel free to contact Birgitte Kaae R&D Manager, Systems Integration & Verification on tel. 2016 3713. Thank you for your interest.

　　Danaher

　　When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.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.If you’ve ever wondered what’s within you, there’s no better time to find out.