Beschreibung
Senior Engineer - Schaffhausen - 100%
Experis is the global leader in professional resourcing and project-based workforce solutions. Our suite of services range from interim and permanent recruitment to managed services and consulting, enabling businesses to achieve their goals. We accelerate organisational growth by attracting, assessing and placing specialised professional talent.
For our international client based in Schaffhausen, Experis is currently looking for a Senior Engineer for a contracting position until, at least, end of 2018.
Tasks & Responsibilities:
* Lead design transfer activities for the device constituent of the combination product
* Collection and creation of design transfer documentation for consideration within the Design History File
* Collection and development of specifications for incoming materials
* Development of control strategy and control plans from incoming inspection to product release testing
* Creation of the Device Master Record
* Creation of Process FMEA in a cross functional team
* Collaborating with site operations, supporting any improvements to the processes and/or equipment,
* Support process and equipment qualification (IQ/OQ/PQ)
You bring for this role the following qualifications:
* A minimum of a Bachelor's degree in Engineering and/or a scientific degree or equivalent combination of education and work experience.
* Experience in the medical devices field is necessary
* A minimum of 5 years of experience in device and packaging field and/or, manufacturing and/or Research and Development.
* Broad scientific or engineering expertise with demonstrable results to deliver new products or sustain existing marketed products is required.
* Experience with FDA regulated Design Control, Change Control and ISO 13485, Medical devices - Quality management systems - Requirements for regulatory purpose, European Medical Device Directive is required.
* Fluent in English (German would be a signifiant plus)
Interested in this opportunity? Kindly send us your CV today through the link in the advert. However should you have any questions please contact Stéphanie Vogt.