Medical Device Engineer

Do you have knowledge within development of drug-device combination products Are you perceived as a structured and constructive person with excellent collaboration skills Would you like to contribute to the quality of life for people with allergy

You might then be the colleague we are looking for.

As Medical Device Engineer 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 design control 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 (DDS) consists of dedicated colleagues with a high team-spirit and competencies within mechanical design medical device development design control usability engineering risk management and clinical evaluation of drug delivery products.

Fields of responsibility:

• Development and test of drug-device combination products throughout entire product life cycle
• Managing and executing technical tasks related to design verification and transfer of design from R&D to production
• Development implementation and documentation of test methods and equipment
• Planning execution and documentation of process validation
• Trouble shooting and root cause analysis
• Writing reviewing and updating product requirements (Design Control)
• Execution of change control deviation handling and CAPAs

Your qualifications:

• . degree . degree or similar within medical devices mechanical engineering or equivalent educational background
• Newly graduate or 3-5 years of experience preferably within Medical Device - Drug Combination products
• Understanding of industry regulations as it pertains to medical devices external standards design controls quality controls and manufacturing methods
• Preferably knowledge on interpreting international standards such as ISO 11608 EN ISO 13485 EN ISO 14971
• Preferably knowledge on regulatory areas relating to medical device/drug-device combination product development e.g. cGMP and design controls
• Knowledge about Risk Management processes and FMEA

In addition we expect you to:

• Have a structural approach to problem-solving and documentation
• Thrive in a small dynamic team of highly qualified employees all with a deep technical background and understanding
• Preferably previous working experience from the Pharmaceutical Device Industry (or similar) preferably with experience within device development device testing and production facilities
• Have a proactive curious and positive mindset are open-minded and thrive in navigating in a dynamic and sometimes complex environment
• Acts operationally and have excellent written and verbal communication skills in English.

Application:

For further information about this role please contact Tine Albeck Director Device Development and

Apply:

Please apply by attaching your CV and a short letter of motivation no later than 3^rd of August 2026.