Medical Device Engineer

equires 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:

• 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.

Application:

For further information about this role, please contact Tine Albeck, Director Device Development and Support, +45 22495026.

Apply: