Roche
Principal Device Engineer with Pen- / Autoinjector expertise(m/w/x)
Full-timeOn-siteSenior
Basel
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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.
Requirements
- 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
Tasks
- 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
Work Experience
- 10 years
Education
- Bachelor's degree
Languages
- English – Native
- German – Business Fluent
Tools & Technologies
- CAD
- FEM
- Monte Carlo
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Roche and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Not a perfect match?
- F. Hoffmann-La Roche AG
Senior Device Engineer with Pen- / Autoinjector expertise(m/w/x)
Full-timeOn-siteSeniorBasel - Roche
Medical Device Platform Design Engineer(m/w/x)
Full-timeOn-siteExperiencedBasel - 1201 F. Hoffmann-La Roche AG
Senior Device Engineer(m/w/x)
Full-timeOn-siteManagementBasel - Roche
Medical Device Platform Lead - Autoinjector(m/w/x)
Full-timeOn-siteSeniorBasel
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 10 years
Education
- Bachelor's degree
Languages
- English – Native
- German – Business Fluent
Tools & Technologies
- CAD
- FEM
- Monte Carlo
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Roche and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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?
- Roche
Principal Device Engineer with Pen- / Autoinjector expertise(m/w/x)
Full-timeOn-siteSeniorBasel - F. Hoffmann-La Roche AG
Senior Device Engineer with Pen- / Autoinjector expertise(m/w/x)
Full-timeOn-siteSeniorBasel - Roche
Medical Device Platform Design Engineer(m/w/x)
Full-timeOn-siteExperiencedBasel - 1201 F. Hoffmann-La Roche AG
Senior Device Engineer(m/w/x)
Full-timeOn-siteManagementBasel - Roche
Medical Device Platform Lead - Autoinjector(m/w/x)
Full-timeOn-siteSeniorBasel