Senior Medical Device Engineer – Device Development and Support

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 Senior Medical Device Engineer you will be joining a team of medical device engineers 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.

Your primary tasks will be:

• Managing and executing technical tasks related to transfer of design from R&D to production.
• Writing reviewing and updating product requirements.
• Planning execution and documentation of process validation.

• Documentation of changes in production.
• Execution of change control deviation handling and CAPAs.

The position is placed at our manufacturing site in Madrid and you will have a close collaboration with colleagues in Denmark. You must expect 10-15 travel days yearly.

Your profile
Your qualifications/experience cover:

• ./. degree or similar within medical devices; mechanical engineering or equivalent educational background.
• Experience in the medical device industry.
• Understanding the industry regulations as it pertains to medical devices external standards design controls quality controls and manufacturing methods.
• Knowledge 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 of Risk Management processes.

In addition we prefer that you:

• Have a structured approach to problem solving and documentation.
• Are hands-on with creative problem solver and solid trouble-shooting skills.
• Have a pioneer spirit we are building a new function in ALK.
• Are a team player you must show flexibility and interest in helping each other.
• Interpersonal skills you have proven relationship building skills and can work cross cultural.
• Can work independently on broad tasks with minimal supervision.
• You speak and write English fluently.

Become a part of ALK
We provide an attractive working environment for individuals looking for both personal and professional development. ALK is a global pharmaceutical company specialized in allergy immunotherapy. We are driven by a high level of professionalism integrity an openminded approach and contributing to an inspiring and fun working environment together with our colleagues. You will be part of an engaged and informal team who values skill and knowledge creation.

Do you want to learn more about our company we encourage you to visit us at .

Apply
Apply by attaching your CV no later than 3 July 2026.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We evaluate applications and call for interviews on an ongoing basis so dont wait to apply! We reserve the right to take down the advert when we have found the right candidate.

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

We are looking forward to hearing from you!