Medical Device Engineer/Technician

The position

Do you have technical flair and an understanding of product design? Do you have experience in the medical device industry? You might then be the colleague we are looking for.

As Medical Device Engineer/Technician, you will be joining a team of medical device engineers and scientists working in the cross-field between device development, production transfer and technical support to the production site. The position requires understanding of product design and development methodologies to develop new or refined materials, processes, or technical methods and deliver the required support to established manufacturing operations.

Our team, Device Development and Support, is a small team of dedicated colleagues with a high team-spirit. The position is located in Hørsholm.

Fields of responsibility

• Managing and executing technical tasks related to transfer of design from R&D to production
• Writing, reviewing and updating product requirements (Design Control)
• Planning, execution and documentation of process validation
• Documentation of changes in production
• Execution of change control, deviation handling and CAPAs
• Medical device testing, analysis and reporting

Your qualifications

• M.Sc./B.Sc. degree or similar within medical devices, mechanical engineering or equivalent educational background
• Experience in the medical device industry
• Understanding of industry regulations as it pertains to medical devices, external standards, design controls, quality controls, and manufacturing methods
• Knowledge on interpreting international standards such as ISO 11608, EN ISO 13485, EN ISO 14971
• Knowledge and experience with regulatory areas relating to medical device/drug-device combination product development, e.g. cGMP and design controls
• Knowledge about Risk Management processes

In addition, we expect you to

• Have a structural approach to problem-solving and documentation
• Be a hands-on person
• Have a pioneering spirit – we are building new function in ALK
• Be a team player – you must show flexibility and we help each other
• Have interpersonal skills; strong and proven relationship building skills/cross-cultural skills
• Be able to work independently on broad tasks and minimal supervision
• Speak and write English fluently

We offer

ALK provides a dynamic and pleasant work environment, complete with inspiring and challenging assignments. The results of your efforts will be significant throughout the organization and you will be able to actively influence and challenge the status quo. Our flat structures attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process. You will be part of an engaged and informal team who values skill and knowledge creation. We consider our pioneering spirit coupled with our trustworthiness our winning formula. ALK is a health-focused organization and our offices offer a green view of the DTU Science Park in Hørsholm.

We look forward to hearing from you.

Application deadline

Send us your application and CV no later than December 13th,2019.

Contact

For further information on the position, please contact Rolf Singer, Senior Director, at e-mail [email protected] or telephone: +45 78 77 45 21.