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Medical Device Design Verification specialist

We are creating a new skilled team consisting of our experienced colleagues with deep domain knowledge about our Blood Gas Analyzers and syringes. Furthermore, the team has strong capabilities within Design Control and documenting product design changes. To keep our project timeline for the EU MDR / IVDR legislation we are looking to add 6 new team members.

 

Contribute to a top priority project

Reviewing and updating all product documentation to follow new MDR / IVDR guidelines requires us to keep ensuring that previous internal documentation has limited gaps compared to future requirements. This job gives you the opportunity to join our team, work with and learn about the clinical use and performance of our highly praised technology related to Blood Gases.

 

Responsibility

  • Perform verification of IVD equipment
  • Ensure on time delivery of updating documentation for MDR/IVDR
  • Close gap on documentation, including technical writing
  • Data analysis and data conclusions. Analyzing our current data and comparing it with future requirements to ensure and document the fast and reliable measurement performance in our products
  • Problem Solving Processes and team collaboration
  • Daily Visual Management and working with our Danaher Business System (DBS) Toolbox to delegate and track progress for tasks in the project
  • Help ensure new data by setting defining test requirements if needed

 

Working together as one strong team

Along with your colleagues in R&D in our HQ in Brønshøj / Copenhagen, collaboration will be needed with R&D colleagues in Poland and external consultants in India. In Copenhagen weekly collaboration with QA, RA, Clinical & Medical Affairs and Operations is also to be expected.

 

Build competencies for the future in an outstanding R&D team

For many technically interested employees Radiometer's products have always been fascinating. Getting close to the products and understanding the data behind their performance is a good opportunity for anyone with an interest in how the combination of technical areas work. We combine forward-thinking minds within chemistry, biology, mechanics, electronics, software and hardware to succeed.

 

We have no doubt that you can learn and grow in the setup ahead of concluding our project successfully in May 2022. Afterwards the skills and knowledge will be invaluable assets for future equally important strategic projects in our R&D organization. When that time come we are excited about utilizing your acquired skills in these projects.

 

Qualifications

We expect that you have a bachelor's, master's or PhD within a technical field (eg. within engineering, physics, chemistry, pharmacy or similar). This combined with most of the following increases your chances of success:

  • Several years of demonstrated ability related to Product development in a Medical Device or combination product environment - most likely in an R&D or QA team
  • Knowledge and understanding of MDR and IVDR legislation
  • ISO 13485 experience
  • Good collaboration skills and team orientation
  • Flair for writing documentation or STED file is a plus

 

Radiometer offers

An outstanding opportunity to work with people, who are passionate about making a difference for healthcare professionals. We offer benefits such as a good culture related to working from home, competitive salary and reward frameworks along with plenty of learning and development opportunities. We are among other things known for our DBS toolbox and the many benefits our employees have from mastering these skills.

 

Recruitment Timeline

Please apply online as soon as possible. We are recruiting a big volume of employees and expect to identify candidates for interviews continuously throughout September and October. We look forward to hearing from you.

 

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.


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