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Engineering Consultant
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Engineering, Consultant, Engineer
Projektbeschreibung
For a 9 month project with our pharmaceutical client in Schaffhausen, we are looking ASAP for an Engineering Consultant in Packaging.
The Senior Engineer will support the implementation of the device constituent and secondary packaging for combination products and will be responsible for design transfer activities including qualification of manufacturing equipment and process validation. This position will also be in a close collaboration with the Packaging COE to facilitate and contribute to the successful introduction of new packaging components and corresponding packaging process.
Your key responsibilities will include
" Design transfer/technology transfer/commercialization activities including process and equipment qualification (IQ/OQ/PQ),
" Verification and validation of test process and test fixtures to meets targeted test coverage and effectiveness.
" Preparation and oversight of packaging development activities including preparation and organization of transportation studies.
" Collection and analysis of test data to identify problems, optimize processes and drive continuous process improvements including feedback to suppliers, manufacturing and development engineering.
" Collection of design transfer documentation for consideration within the Design History File
" Collaborating with site operations, supporting any improvements to the processes and/or equipment, to ensure reliability at the highest possible levels
For this diversified position we are looking for a team player with strong organizational skills who has the ability to focus on complex topics and operates with professionalism.
The following hard skills are required
" A minimum of a Bachelors degree in Engineering and/or a scientific degree or equivalent combination of education and work experience.
" A minimum of 5 years of experience in medical device field and/or, manufacturing and/or Research and Development (R&D).
" Broad scientific or engineering expertise with demonstrable results to deliver new products or sustain existing 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 both German and English
The Senior Engineer will support the implementation of the device constituent and secondary packaging for combination products and will be responsible for design transfer activities including qualification of manufacturing equipment and process validation. This position will also be in a close collaboration with the Packaging COE to facilitate and contribute to the successful introduction of new packaging components and corresponding packaging process.
Your key responsibilities will include
" Design transfer/technology transfer/commercialization activities including process and equipment qualification (IQ/OQ/PQ),
" Verification and validation of test process and test fixtures to meets targeted test coverage and effectiveness.
" Preparation and oversight of packaging development activities including preparation and organization of transportation studies.
" Collection and analysis of test data to identify problems, optimize processes and drive continuous process improvements including feedback to suppliers, manufacturing and development engineering.
" Collection of design transfer documentation for consideration within the Design History File
" Collaborating with site operations, supporting any improvements to the processes and/or equipment, to ensure reliability at the highest possible levels
For this diversified position we are looking for a team player with strong organizational skills who has the ability to focus on complex topics and operates with professionalism.
The following hard skills are required
" A minimum of a Bachelors degree in Engineering and/or a scientific degree or equivalent combination of education and work experience.
" A minimum of 5 years of experience in medical device field and/or, manufacturing and/or Research and Development (R&D).
" Broad scientific or engineering expertise with demonstrable results to deliver new products or sustain existing 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 both German and English
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Organisation/Management