Would you like to use your assembly process expertise to develop state-of-the-art manufacturing solutions which will ensure safe and reliable medical devices? Do you want to be part of our growing journey and support the ramp up to full scale production – or even join daily operations? Then look no further! Take this rare opportunity and join our Device Manufacturing & Sourcing II (DMS II) department as Mechanical Assembly Process Engineer.


The position

As Mechanical Assembly Process Engineer you will be responsible for the assembly lines in our plant and at our Contract Manufacturing Organisations (CMO’s). These fully automated assembly lines put together the individual components into medical device pre-assemblies. You will play a crucial role along the journey from concept development to full scale operation. You will collaborate closely with project managers and colleagues in device manufacturing development, bringing in valuable insights and requirements from an operational point of view. Upon finalization of the development and validation phase, you could become the process owner who is responsible for ensuring flawless, safe, and compliant operation of the assembly lines running around the world.

As such, you will:

Participate in requirement definition, concept design of new equipment, design reviews and acceptance testing (including review and approval of relevant documents) as well as development of training plans and material for operators and technicians
Contribute to validation approach: write test plans and validation protocols and reports as well as supporting the execution of tests and validation activities
Explore and test emerging technologies to support our journey towards Industry 4.0
Ensure robustness of products and processes through efficient and standardised validation processes and through development of solid operational procedures, and efficient service and maintenance plans in close collaboration with equipment suppliers, technicians, and operators
Develop and improve assembly processes, share best practice across production sites and facilitate technology transfer to Contract Manufacturing Organisations.
Monitor operational performance of the equipment based on data and ensure that the validated state is maintained, troubleshoot issues

The position is located in Odense, but for the first 1-2 years, frequent travels to Hillerød/Greater Copenhagen area will be required. You should also expect international travel to equipment vendors and CMO's.

Qualifications

To be considered for this position, we imagine you:

Hold at least a Bachelor’s degree in Engineering or any other related field
Have assembly process work experience ideally obtained within a manufacturing development and/or GMP production of medical devices
Possess knowledge of process validation
Be fluent in English, both written and spoken