Medical Device Engineer for Device Development and Support in Global CMC Development

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 profile
Your qualifications covers

• M.Sc. degree, B.Sc. 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.

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 specialised 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. The culture is informal yet professional, encouraging a strong work-life balance while driving performance excellence.

Our offices in Denmark offer a green view of the DTU Science Park in Hørsholm. We believe that physical presence enforces strong teamwork and collaboration and creates success, so it is important that you enjoy coming to work at our site with a degree of flexibility to also work from home.

Do you want to learn more about our company, we encourage you to visit us at www.alk.net.

Apply
Apply by attaching your CV and a short letter of motivation, no later than 19 January 2025.

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 don't wait to apply! We reserve the right to take down the advert when we have found the right candidate.

For further information regarding the position, please contact Associate Director, Tine Albeck on +45 22 49 50 26.

We are looking forward to hearing from you!