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Design Control Specialist - New Instrument Development

About Us

At Radiometer, our mission is to help caregivers make diagnostic decisions that save lives. To provide caregivers the insight and confidence that help them arrive at the right diagnostic decisions – decisions that in the end help save lives. On a yearly basis millions of lives are touched by the information our solutions provide and that’s a fact, we take very seriously; the more critical the setting, the greater the requirements are and that’s why we’ve made it our vision to improve global healthcare with reliable, fast and easy patient diagnoses. Want to know more about our mission and vision? Click on the link: https://www.youtube.com/watch?v=VklR-M9tsjU

Our people

At Radiometer, we acknowledge that the information our products provide is often the difference between life and death; an acknowledgement that drives and unites us as a company. From biotech and software specialists to financial controllers and engineers, all 3200 colleagues are committed and dedicated to help realize life’s potential.


If you aspire to be part of a purpose, performance and values driven organization whose mission and vision guide every action, we are eager to hear from you. 

Description

You are probably recognized for your ability to understand complex products and you love the cross-functional collaboration with other passionate engineers that enable new valuable products to be designed safely and efficiently. You know that your ability to create structure and understand the regulatory requirements and documentation helps deliver development projects within deadline.


Now is your chance to help us finish the development of our next generation bloodgas analyzer that will help save the lives of patients all over the world.


Dedicated project team

You will join a large team of passionate and diverse employees. Knowledge sharing and team spirit is very present and we are fully committed to deliver the project on time with high quality. Your role is to lead the requirement engineering process and design control documentation in the project in close cooperation with the project team and key stakeholders.You report to Head of New Instrument Development in R&D.


Systems engineering and documentation

Your most important responsibility is to lead the systems engineering process including architecture and system requirements, and develop these into lower level requirements specifications. You can look forward to exciting cross-collaboration between many different functions that include:

• R&D (software, mechanical, electrical, chemical, usability, and test) 

• QA and RA 

• Marketing

• Technical Publications

• Production Building relations to these stakeholders is an interesting privilege and challenge in the job as close alignment ensure the most efficient documentation package.


Contribute, grow and develop 

Radiometer is a growing organization always developing through LEAN management tools and values. It makes it fun and meaningful to be part of an organization where your thoughts and ideas are embraced by management and can make a true impact. Developing on a personal and professional level is of a high importance for everyone in Radiometer and that is why we have many employees building and developing their careers for many years in Radiometer and Danaher. 


Application deadline is Friday 20 April 

Start the application process by clicking "Apply Online" and follow the guidelines on our corporate career site. Please attach your CV and other relevant documents. 
If you have any questions feel free to contact Hiring Manager, Søren Karsberg, phone +45 20 73 04 32. We look forward to receiving your application.
 

Qualifications

The preferred candidate holds a Master Degree in Engineering (chemistry, electrical, mechanical), Pharmacy, or similar. This combined with most of the following increases your chances of success in the job:
• 3-5 years of experience with regulatory assignments in engineering development projects 

• Experience within requirements engineering, risk management and design control 

• Knowledge of regulatory legislation (IVD or MDD) in EU and US

• Ability to finalize tasks within deadlines

• Experience with work relations in different cultures

• Used to cross-functional interaction and collaboration 

 

Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% over 20 years.


At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.


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