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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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- F. Hoffmann-La Roche AGFull-timeOn-siteSeniorBasel
- 1201 F. Hoffmann-La Roche AG
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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
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
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
Principal Design Engineer(m/w/x)
Full-timeOn-siteSeniorBasel - Roche
Medical Device Platform Lead - Autoinjector(m/w/x)
Full-timeOn-siteSeniorBasel - Roche
Medical Device Platform Design Engineer(m/w/x)
Full-timeOn-siteExperiencedBasel