Roche
Principal Device Engineer with Pen- / Autoinjector expertise(m/w/x)
Vollzeitnur vor OrtSenior
Basel
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
RORoche
Principal Design Engineer(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Digital Twins for drug delivery device performance verification at global healthcare firm. 10+ years mechanical engineering and pen/auto-injector development required. 4-day work week.
Anforderungen
- University-level education (engineering degree or related)
- Minimum 10-year track record in mechanical engineering and drug delivery device development in pharma or regulated environments (cGxP, QSR)
- Hands-on Pen injector / Auto injector development expertise
- Strong engineering expertise including CAD construction, Simulation (FEM, Monte Carlo), reliability engineering, and Material Science
- Demonstrable knowledge of Tolerance Analysis, statistical techniques, process capability, and manufacturing processes
- Sound knowledge of legislation, industry standards, and experience with Health Authority interactions
- Demonstrated application of Lean management principles in technical development
- Excellent documentation, presentation, and interpersonal communication skills
- Excellent command of English language; proficiency in German is preferable
Aufgaben
- Act as a technical expert for product market launch
- Lead new technology evaluations
- Apply advanced engineering theory for requirements
- Develop reliable design solutions
- Use Digital Twins for performance verification
- Assess design robustness via simulation
- Perform finite element analysis (FEA)
- Conduct tolerance analysis
- Utilize predictive engineering tools
- Optimize designs for large-scale production
- Leverage expertise in injection molding
- Apply knowledge of tool design
- Use mold flow analysis
- Author design control documentation
- Create Design Development Plans
- Write User Requirement Specifications (URS)
- Define Design Inputs/Outputs
- Develop Design Verification Plans
- Create and maintain Design History Files (DHF)
- Perform conformity assessments
- Generate risk management documentation
- Forecast resource demands for projects
- Plan device development projects
- Execute projects within time constraints
- Deliver projects within quality constraints
- Manage projects within cost constraints
- Apply Lean management principles
- Ensure standard compliant designs
- Apply knowledge of ISO 13485
- Apply knowledge of 21CFR820
- Apply knowledge of ISO 14971
- Apply knowledge of 21 CFR 820.30
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – verhandlungssicher
Tools & Technologien
- CAD
- FEM
- Monte Carlo
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Roche erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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Digital Twins for drug delivery device performance verification at global healthcare firm. 10+ years mechanical engineering and pen/auto-injector development required. 4-day work week.
Anforderungen
- University-level education (engineering degree or related)
- Minimum 10-year track record in mechanical engineering and drug delivery device development in pharma or regulated environments (cGxP, QSR)
- Hands-on Pen injector / Auto injector development expertise
- Strong engineering expertise including CAD construction, Simulation (FEM, Monte Carlo), reliability engineering, and Material Science
- Demonstrable knowledge of Tolerance Analysis, statistical techniques, process capability, and manufacturing processes
- Sound knowledge of legislation, industry standards, and experience with Health Authority interactions
- Demonstrated application of Lean management principles in technical development
- Excellent documentation, presentation, and interpersonal communication skills
- Excellent command of English language; proficiency in German is preferable
Aufgaben
- Act as a technical expert for product market launch
- Lead new technology evaluations
- Apply advanced engineering theory for requirements
- Develop reliable design solutions
- Use Digital Twins for performance verification
- Assess design robustness via simulation
- Perform finite element analysis (FEA)
- Conduct tolerance analysis
- Utilize predictive engineering tools
- Optimize designs for large-scale production
- Leverage expertise in injection molding
- Apply knowledge of tool design
- Use mold flow analysis
- Author design control documentation
- Create Design Development Plans
- Write User Requirement Specifications (URS)
- Define Design Inputs/Outputs
- Develop Design Verification Plans
- Create and maintain Design History Files (DHF)
- Perform conformity assessments
- Generate risk management documentation
- Forecast resource demands for projects
- Plan device development projects
- Execute projects within time constraints
- Deliver projects within quality constraints
- Manage projects within cost constraints
- Apply Lean management principles
- Ensure standard compliant designs
- Apply knowledge of ISO 13485
- Apply knowledge of 21CFR820
- Apply knowledge of ISO 14971
- Apply knowledge of 21 CFR 820.30
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – verhandlungssicher
Tools & Technologien
- CAD
- FEM
- Monte Carlo
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Roche erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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?
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