Dein persönlicher KI-Karriere-Agent
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- 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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- Pen injector
- Auto injector
- cGxP
- Quality System Regulation (QSR)
- Statistical techniques
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Roche
Branche
Healthcare
Beschreibung
The company is dedicated to advancing science and ensuring access to healthcare for everyone.
Noch nicht perfekt?
- F. Hoffmann-La Roche AG
Senior Device Engineer with Pen- / Autoinjector expertise(m/w/x)
Vollzeitnur vor OrtSeniorBasel - 1201 F. Hoffmann-La Roche AG
Senior Device Engineer(m/w/x)
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Principal Design Engineer(m/w/x)
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Medical Device Platform Technical Lead(m/w/x)
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