Design Control Specialist



Career Opportunities: Design Control Specialist (48004)
Req ID 48004 - Posted 14/01/2020 - Denmark - Capital Region, Humlebæk - Research & Development - Coloplast A/S

Design Control Specialist
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 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
  • Drive the usability engineering process and create the usability engineering report
  • 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
  • Implement requirements originating from standards

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 have experience with design control, product risk management, usability engineering or quality assurance in medical device industry. Furthermore:

  • You have knowledge of regulations, standards and guidelines within the medical device area e.g. MDR, ISO 13485, ISO 14971 and FDA 21 CFR 820.30
  • Experience with driving and documenting design control activities such as the creation of design input and outputs, design verification and facilitating design reviews
  • Experience with facilitating product risk management activities and creating the risk management file
  • Experience with usability engineering
  • 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.

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

Please send your application no later than January 27th 2020. We will take candidates into the recruitment process continuously, so do not hesitate to apply.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with very private and personal medical conditions. Employing more than 12,000 people and with products available in more than 140 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. Curiosity works here.

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Ansøgningsfrist d. 27.01.2020
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Coloplast - hurtigt overblik

Holtedam 1
3050 Humlebæk
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