EXO ARNVIND is looking for a Design Control Specialist for our customer - a global medical device company that develops and market sterile disposable products for subcutaneous infusion of various medications.

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

Our customer is looking for a highly dedicated Design Control Specialist to join their 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 the 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 a high influence on the continuous improvements of their 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.

Our customer offers 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 your 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 a 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.

If the above descriptions could be you – then please apply here at Open Positions

We look forward to hearing from you

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We look forward to working with you!