Design Control Specialist - Medical Devices

ConvaTec Denmark A/S


Design Control Specialist - Medical Devices

Are you passionate about developing products that improve people’s live? Do you want to join a world leading company specialized in treatment of chronic diseases such as Diabetes and Parkinson’s Disease? Then you might be the right candidate to join our R&D organization.

We are looking for a highly dedicated Design Control Specialist to join our R&D organization. In this role, you are responsible for the product documentation during all phases of the project where you will drive the design control processes and write main part of the technical documentation in close collaboration with a cross-functional project team and key stakeholders. You will participate in the planning of all design control activities, ensure standard operating procedures and instructions are followed and documented with high quality. You are responsible for keeping the Design History File updated and structured. In the job, you will have high influence on the continuous improvements of our standard operating procedures and instructions.

You will report to the Product Quality and Documentation Manager and be a part of a team of 10 highly competent colleagues responsible for design control activities, technical documentation, product quality and PDM system.

We offer you a central role in an exciting company in constant growth. You will work in a dynamic team with international exposure and a multi-cultural organization. Up to 10 - 20 travel days yearly is to be expected.

Professional Qualifications:

You hold a Master or bachelor’s degree in engineering, pharmacy, quality or similar. This, combined with most of the following increases you chance of success in the job.

  • Minimum 3 years of experience in Medical Device product development (Class II)
  • Hands-on experience with Design Control in accordance with EU ISO 13485, US 21CFR820 Quality Systems for Medical Devices, and MDR
  • Experience with requirements engineering, product risk management, and usability engineering
  • Knowledge within regulatory legislations and standards

Personal Qualifications:

Besides having a solid experience within design control and good documentation practices you are a team player with excellent communication skills. You utilize your good collaboration skills to build strong collaboration with other functions like QA, RA, Marketing, and Production. You operate with a sense of urgency to meet your deadlines while keeping high quality standards. You enjoy a busy working day and can progress several tasks in parallel. You have excellent written and verbal communication skills in English and Danish.

For further information:

Do not hesitate to contact Søren Karsberg, R&D Director, at cell phone +45 2073 0432 or e-mail:

Relevant candidates will be called for interviews even before the application period is closed.

ConvaTec, Infusion Care Division / Unomedical a/s is a global Medical Device company specialized in the treatment of chronic diseases, such as Diabetes Mellitus and Parkinson’s Disease. We develop and market sterile disposable products for subcutaneous infusion of various medications. Our manufacturing facilities in Denmark and Mexico produce more than 100 million infusion sets per year, making us the world leader within this field. Our R&D function, with 40 people is situated in Osted, Denmark, making sure that new products meet highest industry standards, satisfy patient needs and comply with applicable regulatory requirements. Further information about the company can be found at our website or

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Fødevarer & Veterinær
Medicinal & Sundhed
Produktion, Logistik & Transport
Teknik & Teknologi
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Forskning & Udvikling
Medicinal & Sundhed

ConvaTec Denmark A/S - hurtigt overblik

ConvaTec Denmark A/S
ConvaTec Denmark A/S
ConvaTec er en global producent af medicotekniske produkter med ledende markedspositioner indenfor stomipleje, sårbehandling, kontinens, intensivbehandling og subkutan infusionsterapi.

Skinderskovvej 32-36
2730 Herlev
Logo: ConvaTec Denmark A/S
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