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Principal Device Engineer with Pen- / Autoinjector expertise(m/w/x)
Leading projects for combination products, evaluating breakthrough medical device technologies. 10-year mechanical engineering track record and combination product legislation knowledge required. Work in a mission-driven environment for global healthcare access.
Requirements
- University degree in engineering or related
- 10-year track record in mechanical engineering
- Pen or Auto injector development expertise
- Knowledge of combination product legislation
- Experience with Health Authority interactions
- Knowledge of drug delivery and reliability
- Excellent communication and strategic thinking
- Excellent English and preferable German proficiency
Tasks
- Lead projects and technical teams to market combination products
- Evaluate new and breakthrough medical device technologies
- Establish robust technical product requirements using engineering knowledge
- Develop design solutions to ensure long-term device performance
- Author design control and risk management documentation
- Create and maintain Design History Files and conformity assessments
- Forecast and plan resource demands for development projects
- Execute projects within time, quality, and cost constraints
- Ensure designs comply with global regulatory standards
Work Experience
- 10 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- Pen injector
- Auto injector
- cGxP
- Quality System Regulation (QSR)
- Statistical techniques
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Principal Device Engineer with Pen- / Autoinjector expertise(m/w/x)
Leading projects for combination products, evaluating breakthrough medical device technologies. 10-year mechanical engineering track record and combination product legislation knowledge required. Work in a mission-driven environment for global healthcare access.
Requirements
- University degree in engineering or related
- 10-year track record in mechanical engineering
- Pen or Auto injector development expertise
- Knowledge of combination product legislation
- Experience with Health Authority interactions
- Knowledge of drug delivery and reliability
- Excellent communication and strategic thinking
- Excellent English and preferable German proficiency
Tasks
- Lead projects and technical teams to market combination products
- Evaluate new and breakthrough medical device technologies
- Establish robust technical product requirements using engineering knowledge
- Develop design solutions to ensure long-term device performance
- Author design control and risk management documentation
- Create and maintain Design History Files and conformity assessments
- Forecast and plan resource demands for development projects
- Execute projects within time, quality, and cost constraints
- Ensure designs comply with global regulatory standards
Work Experience
- 10 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- Pen injector
- Auto injector
- cGxP
- Quality System Regulation (QSR)
- Statistical techniques
About the Company
Roche
Industry
Healthcare
Description
The company is dedicated to advancing science and ensuring access to healthcare for everyone.
Not a perfect match?
- F. Hoffmann-La Roche AG
Senior Device Engineer with Pen- / Autoinjector expertise(m/w/x)
Full-timeOn-siteSeniorBasel - 1201 F. Hoffmann-La Roche AG
Senior Device Engineer(m/w/x)
Full-timeOn-siteManagementBasel - Roche
Global Head of Device Technology and Strategy(m/w/x)
Full-timeOn-siteSeniorBasel - Novartis
Senior Expert Engineering – Assembly for Medical Device(m/w/x)
Full-timeOn-siteSeniorBasel - 1201 F. Hoffmann-La Roche AG
Device Process Engineer - Global MSAT(m/w/x)
Full-timeOn-siteSeniorBasel