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Senior Device Engineer(m/w/x)
Leading pen/auto injector development projects for combination product launches at global pharma/medtech company. Hands-on pen/auto injector development expertise essential; 5+ years in drug delivery device development required. Global project coordination with cross-functional teams.
Anforderungen
- University level education in engineering or related discipline
- Minimum 5 years proven track record in mechanical engineering and drug delivery device development
- Hands-on Pen injector / Auto injector development expertise
- Sound knowledge of legislation, regulation, industry standards, and guidance for combination products and medical devices
- Experience with Health Authority interactions
- Demonstrable knowledge of drug delivery devices and parenteral drug delivery
- Excellent documentation, presentation, and interpersonal communication skills
- Excellent command of English; proficiency in German preferable
Aufgaben
- Lead projects and teams to launch combination products and medical devices
- Evaluate new and breakthrough technologies
- Establish robust technical product requirements
- Develop engineering design solutions for device performance
- Author design control documentation, including development plans and specifications
- Create and maintain design verification plans and DHF documentation
- Conduct conformity assessments and manage risk documentation
- Forecast and plan resource demands for device development projects
- Execute projects within time, quality, and cost constraints
- Ensure designs comply with regulatory standards, including ISO 13485 and 21CFR820
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Noch nicht perfekt?
- F. Hoffmann-La Roche AGVollzeitnur vor OrtSeniorBasel
- Roche
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Vollzeitnur vor OrtSeniorBasel - Novartis
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Vollzeitnur vor OrtSeniorBasel - 1201 F. Hoffmann-La Roche AG
Device Process Engineer - Global MSAT(m/w/x)
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Global Head of Device Technology and Strategy(m/w/x)
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Senior Device Engineer(m/w/x)
Leading pen/auto injector development projects for combination product launches at global pharma/medtech company. Hands-on pen/auto injector development expertise essential; 5+ years in drug delivery device development required. Global project coordination with cross-functional teams.
Anforderungen
- University level education in engineering or related discipline
- Minimum 5 years proven track record in mechanical engineering and drug delivery device development
- Hands-on Pen injector / Auto injector development expertise
- Sound knowledge of legislation, regulation, industry standards, and guidance for combination products and medical devices
- Experience with Health Authority interactions
- Demonstrable knowledge of drug delivery devices and parenteral drug delivery
- Excellent documentation, presentation, and interpersonal communication skills
- Excellent command of English; proficiency in German preferable
Aufgaben
- Lead projects and teams to launch combination products and medical devices
- Evaluate new and breakthrough technologies
- Establish robust technical product requirements
- Develop engineering design solutions for device performance
- Author design control documentation, including development plans and specifications
- Create and maintain design verification plans and DHF documentation
- Conduct conformity assessments and manage risk documentation
- Forecast and plan resource demands for device development projects
- Execute projects within time, quality, and cost constraints
- Ensure designs comply with regulatory standards, including ISO 13485 and 21CFR820
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Über das Unternehmen
1201 F. Hoffmann-La Roche AG
Branche
Healthcare
Beschreibung
Roche is dedicated to advancing science and ensuring access to healthcare for everyone, with over 100,000 employees globally.
Noch nicht perfekt?
- F. Hoffmann-La Roche AG
Senior Device Engineer with Pen- / Autoinjector expertise(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Roche
Principal Device Engineer with Pen- / Autoinjector expertise(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Novartis
Senior Expert Engineering – Assembly for Medical Device(m/w/x)
Vollzeitnur vor OrtSeniorBasel - 1201 F. Hoffmann-La Roche AG
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