Device Technical Manager
An exciting opportunity has arisen for a Device Technical Manager to join a dynamic company in Iceland. This organisation places strong emphasis on excellence and commitment to improving the lives of patients by making biologics more accessible around the globe. For the successful candidate, a full relocation package is available, including a cash allowance and free accommodation for the first month.
- Leads their development project and documentation thereof from start to finish including human factors (usability) testing, design verification testing, and product finalization.
- Develop and maintain technical subject matter expertise in the function and testing of the devices that are part of the combination drug product.
- Develop and maintain a working knowledge of regulations surrounding combination drug products.
- Draft source documents for dossier filing, contribute to risk assessments and SOPs
- Works with QA to maintain Design History File.
- Co-ordinates and maintains samples for shipment with supply chain.
- Day to day coordination of technical projects with vendors and reviews all technical documents
- Coordinates outsourced engineering and assembly activities.
Skills and Requirements
- MSc. Preferred. BSc. Equivalent minimally. Engineering, pharmaceutical sciences, biochemistry or related field.
- The candidate must have a demonstrated ability to manage projects (academic or industrial).
- The candidate must be organized, take initiative, be prepared to challenge and have strong communication skills.
- The employee shall take the initiative when solving a task assigned to him/her and do whatever is necessary to solve it.
- It is important that an employee has the company values at heart in his/her work.
- An employee shall be actively involved in tasks that involve other departments in the company, in addition to other tasks assigned to him/her.
In case you have difficulty in applying or if you have any questions, please contact Kelly Reinecke Marshall at +496950608633 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.