As 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 in order to develop new or refined materials, processes, or technical methods and deliver the required support to established manufacturing operations.
- 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.
- M.Sc./B.Sc. degree or similar within medical devices; mechanical engineering, technical writer or equivalent educational background
- Preferably 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:
- You have a structural approach to problem solving and documentation
- Be a hands-on , creative problem solver with solid trouble-shooting skills
- Have a pioneer spirit - we are building a new function in ALK
- Be a team player - you must show flexibility and we help each other
- Interpersonal skills - strong and proven relationship building skills/cross cultural skills
- You speak and write English fluently
- Able to work independently on broad tasks and minimal supervision.
If you would like any additional information on this position please contact Rolf Singer, Director Device Development and Support on (+45) 6191 1038.
How to apply
Please click on apply and kindly remember to attach a letter of motivation and CV. We are looking forward to hearing from you.
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