Design Control Specialist for medical device product development
Are you passionate about developing products that improve people’s lives? 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 ConvaTec’s R&D organization.
ConvaTec develops and produces sterile products for infusion of various medications for treatment of chronic diseases, such as diabetes and Parkinson’s Disease. Convatec has 9.400 employees and 300 of these will become your colleagues in Osted, south of Roskilde.
The company is steadily growing, and we are now looking for a highly dedicated Design Control Specialist to join the 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 the update and the structure of the Design History File. In the job, you will have high influence on the continuous improvements of our standard operating procedures and instructions.
You will report to the R&D Director and be a part of a team of 18 highly competent colleagues responsible for design, documentation and project management.
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.
Your professional qualifications
Master or bachelor’s degree in engineering, pharmacy, quality or similar
- 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
- Experience with requirements engineering, product risk management, and usability engineering
- Knowledge within regulatory legislations and standards
Your personal qualifications
Besides having a solid experience with 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. Being good at speaking Danish is not a requirement but could be an advantage.
At ConvaTec you will experience the satisfaction of working for a higher purpose helping people all over the world to have a better life. You will have the advantages of being a part of a small organization with a flat organizational structure, where you will have great influence.
Convatec offers a competitive salary package, a good canteen arrangement and monthly opportunities for various activities arranged by the local staff association.
Please open the “Søg stilling” link and thereby upload your application and CV.
For any inquiries, please contact Senior Recruitment Consultant Erik Bernskov at Hartmanns by e-mail: firstname.lastname@example.org or phone: +45 41 21 13 29 (ferie i ugerne 29-31). As Hartmanns A/S is responsible for the full recruitment process, all inquiries should be directed to this contact.
Hartmanns interviews candidates on an ongoing basis.
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 25 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 www.convatec.com
- Ansøgningsfrist 29-08-2019
eller ring +45 4121 1329