Design Control Specialist - Maternity Cover

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Humlebæk

Are you motivated working with design control, risk management and usability, and do you want to make a difference in exciting innovative R&D projects?

Would you like to enter a creative R&D environment where you participate in developing innovative solutions for users with intimate healthcare needs and where you have solid opportunities for continuous development?

Then join Coloplast in this 1-year position to become part of one of the best performing MedTech companies in the world.

About the department
In Humlebæk, Denmark, you become part of the Design Control & Usability Engineering team, which resides in Medical Affairs, Global R&D. We are a highly engaged team of design control and usability specialists that takes pride in creating high quality documentation through a structured and involving process where we together with other project team members find pragmatic solutions to issues at hand.

Our key objective is to drive standardized and structured design control, risk management and usability engineering processes to support innovative product development solutions that match the users’ needs while ensuring regulatory compliance.

The job
As Design Control Specialist you:

  • Drive design control activities in new product development projects to provide documentation support for the regulatory files and to support clinical studies
  • Responsible for the product risk management process and documentation
  • Contribute to the progress of the product development projects and ensure knowledge sharing across the project team e.g. through facilitating design reviews. This includes planning, reporting and documentation of the work in close cooperation with a variety of stakeholders
  • Update existing documentation to MDR

As you join us, we will make sure to support you, and you will have every chance to develop your expertise.

Your qualifications
You have a degree in engineering, pharmaceutics, life science or similar and it is an advantage if you have experience with design control, product risk management, usability engineering or quality assurance in medical device industry.

Furthermore, you have experience with or is eager to learn the following:

  • Regulations, standards and guidelines within the medical device area e.g. MDR, ISO 13485, ISO 14971 and FDA 21 CFR 820.30
  • Driving and documenting design control activities such as the creation of design input and outputs, design verification and facilitating design reviews
  • Facilitating product risk management activities and creating the risk management file
  • You have a good understanding of complex technical issues
  • You have strong communication skills. Fluent in English – both verbal and written.


On a personal note you are a true team player with a positive and flexible mindset, who understands how to reach joint goals. You have a proactive mind-set and a constructive attitude to drive results combined with the ability to plan, execute and meet deadlines. You enjoy working with multiple tasks at the same time and are analytical and capable of digesting complex data without losing the overall picture.

Interested?
For further information please contact Director of Design Control & Usability Engineering, Marie Hasemann, at +45 4911 1573.

We will take candidates into the recruitment process continuously, so do not hesitate to apply. This position will remain open until a suitable candidate has been found.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 12.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

Visit us on Coloplast.com.

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Information og data

Denne ledige stilling har jobtypen "Forretningsudvikler", og befinder sig i kategorien "Kommunikation, marketing, salg".

Arbejdsstedet er beliggende i Humlebæk.

Jobbet er oprettet på vores service den 26.5.2020, men kan have været deaktiveret og genaktiveret igen.

Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Forretningsudvikler
  • Humlebæk

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