Overview
For our client, an innovative MedTech company specializing in ophthalmology, we are seeking a highly motivated individual to join the Manufacturing Science & Technology team in Schaffhausen.
As a Design Transfer Engineer, you will be responsible for technology transfer activities at the site level, including any scale-up processes. Furthermore, you will support technical transfer project teams on site and liaise effectively with all involved functions (e.g. Development, Supply Chain, Production Unit, Quality Control, HSE, other sites).
Responsibilities
* Works with R&D organization to ensure a robust commercial scale-up of new products.
* Support Design Transfer projects according to local procedures
* Support Technical Transfer activities into and out of the site (cross-functional team)
* Operations representative throughout development projects
* Supporting R&D during Feasibility phase to ensure design for manufacturability including process improvements
* Identifies and supports the introduction of new technologies and equipment (e.g., manufacturing equipment)
* Develops requirements for new equipment (e.g., standard performance targets)
* Provides technical expertise together with site experts
* Defines and monitors project scope, timing and progress
* Writes Manufacturing Process and Design Transfer Documents (protocol, report)
* Coordinates feasibility, regulatory and validation batches at site
* Ensures alignment of (regulatory) timelines for technical changes, transfers or launches and major deviations
* Supports continuous process and quality improvements
Qualifications
* Bachelor’s or Master’s degree in Mechanical Engineering, Medical Engineering, or a related field
* Minimum of 2 years of relevant experience in medical device manufacturing
* Proven experience working in a highly regulated environment (e.g. GxP, ISO 13485)
* Solid expertise in project management
* Fluent in German and English, both written and spoken
* Strong ability to network and collaborate with internal stakeholders from Development, Supply Chain, Production Unit, Quality Control, HSE, other sites
Your application
Please apply online. For further information about the position, please contact your Gi Consultant, Mr. Nazim Sagkol (B. Eng.), (+41 76 349 85 07)
Seniority level
* Associate
Employment type
* Full-time
Industries
* Medical Equipment Manufacturing
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