Design Control Specialist

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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 and 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 R&D. We are a highly engaged team of design control and usability specialists and our key objective is to facilitate and document a 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 incl facilitating requirements engineering and design reviews in a cross functional product development team
  • Create design and development documentation to support the regulatory files and to support clinical studies
  • Responsible for the product risk management process and file
  • Facilitate product risk management reviews with a cross functional product development team
  • Provide input to the usabililty engineering process and documentation
  • 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 preferably, you have experience with:

  • 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 requirement engineering, 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 and is used to work in a cross functional product development team.


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.

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

Deadline
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 15.12.2020, 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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