Operations Development Engineer - Medical devices production
TeesuVac is a start-up that develops medical devices for utilisation in soft tissue needle biopsy. To further expand our development activities, we are seeking a highly skilled and experienced Operations Development Engineer. We are located in Forskerparken Scion DTU, 2970 Hørsholm.
You will be responsible for leading production setup in a cross-functional multidisciplinary project team in close collaboration with an international contract manufacturer. You will engage with the product development team to establish production capabilities for a unique device platform, including processing equipment.
Your key tasks will be as follows:
- Manage the relationship with an international contract manufacturer
- Establish manufacturing processes, as well as related tooling, equipment, fixtures
- Collaborate with the quality assurance team to establish manufacturing documentation
- Manage pilot production, including training of operators
- Develop manufacturing and engineering concepts together with the project team
- Execute validation of product, processes, and equipment
- Engage with domestic and international consultancies and suppliers
The qualifications and core competencies required of you are as follows:
- An engineer with at least a bachelor's degree or equivalent
- Documented experience with production of medical devices
- Experience in establishing production, preferably in collaboration with a contract manufacturer
- Experience with clean room production and sterilization of medical devices
- Experience working with 3D CAD (e.g. SolidWorks, pro/Engineer)
- Fluency in spoken and written English and Danish, and excellent communication skills
Additionally, you should possess a strong personal drive, and you should be persistent and thrive while working in a start-up environment. Finally, it is important that you possess a good understanding of the requirements and standards for medical device registrations in the EU and the USA.
A unique and challenging job in a small entrepreneurial organization where you will come across every opportunity to develop your skills further, and you will have a high level of responsibility while working on an exciting new medical device that makes a difference.
How to apply
If you are interested in the position, then please apply as soon as possible. Please send you’re application and CV to John Hvidkjær on e-mail via the "Ansøg" link.
Please note that we will invite candidates for interviews on a recurring basis. If you have any questions about the position, you can contact John Hvidkjær - telephone +45 6155 8399.
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