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Senior Device Engineer with Pen- / Autoinjector expertise(m/w/x)
Leading development and market introduction of pen/autoinjectors and combination products at pharma provider of active ingredients. Pen/autoinjector development expertise and Health Authority interaction experience required. Global project scope.
Requirements
- University degree in engineering or related discipline
- Minimum 5 years experience in mechanical engineering
- Expertise in Pen or Auto injector development
- Knowledge of combination products and medical devices
- Experience with Health Authority interactions
- Knowledge of drug delivery and manufacturing
- Excellent documentation and communication skills
- Excellent English and preferable German proficiency
Tasks
- Lead projects and teams as a technical expert
- Bring combination products and medical devices to market
- Evaluate new and breakthrough technologies
- Establish robust technical product requirements
- Develop engineering solutions for long-term device performance
- Author design control and risk management documentation
- Create and maintain Design History Files
- Forecast and plan resource demands for development projects
- Execute projects within time, quality, and cost constraints
- Ensure designs comply with global regulatory standards
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- Pen injector
- Auto injector
- cGxP
- Quality System Regulation (QSR)
- Tolerance analysis
- Statistical techniques
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- RocheFull-timeOn-siteSeniorBasel
- 1201 F. Hoffmann-La Roche AG
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Senior Device Engineer with Pen- / Autoinjector expertise(m/w/x)
Leading development and market introduction of pen/autoinjectors and combination products at pharma provider of active ingredients. Pen/autoinjector development expertise and Health Authority interaction experience required. Global project scope.
Requirements
- University degree in engineering or related discipline
- Minimum 5 years experience in mechanical engineering
- Expertise in Pen or Auto injector development
- Knowledge of combination products and medical devices
- Experience with Health Authority interactions
- Knowledge of drug delivery and manufacturing
- Excellent documentation and communication skills
- Excellent English and preferable German proficiency
Tasks
- Lead projects and teams as a technical expert
- Bring combination products and medical devices to market
- Evaluate new and breakthrough technologies
- Establish robust technical product requirements
- Develop engineering solutions for long-term device performance
- Author design control and risk management documentation
- Create and maintain Design History Files
- Forecast and plan resource demands for development projects
- Execute projects within time, quality, and cost constraints
- Ensure designs comply with global regulatory standards
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- Pen injector
- Auto injector
- cGxP
- Quality System Regulation (QSR)
- Tolerance analysis
- Statistical techniques
About the Company
F. Hoffmann-La Roche AG
Industry
Healthcare
Description
Das Unternehmen ist ein führender Anbieter von pharmazeutischen Wirkstoffen und setzt sich für die Gesundheitsversorgung weltweit ein.
Not a perfect match?
- Roche
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