Randstad Professionals is currently looking for an Engineering Consultant (German speaker) who will be assigned an interesting challenge for a major client based in Schaffhausen. This contract is an unique opportunity to join a major client, global group focusing on the Healthcare sector (Medical device, Pharma/vaccines, Consumer health).
The initial assignment will start immediately and will last until December 2018.
Job description:
The Senior Engineer NPI will support the implementation of combination products (self-administration devices) and lead design transfer activities for assigned projects in the client's Supply Chain. This position will be in a close collaboration with the manufacturing sites, suppliers and the PDMS device development team for successful integration of the device components and the corresponding assembly process.
Activities in the scope of a design transfer include but are not limited to process development, equipment qualification and process validation.
Your key responsibilities will include
• Lead design transfer activities for the device constituent of the combination product
• Collection/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),
For this diversified position we are looking for a team player with strong organizational and project management skills.
The following hard skills are required
• A minimum of a Bachelor’s degree in Engineering and/or a scientific degree or equivalent combination of education and work experience.
• A minimum of 5 years of experience in device and packaging field and/or, manufacturing and/or Research and Development (R&D).
• 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 both German and English
If you are interested for this great role, don't hesitate to send your application or to contact me directly. I am looking forward to shraring informations with you.
Olivier Worch
Consultant Life Sciences
T +41 58 201 55 55
olivier.worch@ch.randstad.com