F. Hoffmann-La Roche AG
Senior Device Engineer with Pen- / Autoinjector expertise(m/w/x)
Full-timeOn-siteSenior
Basel
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121201 F. Hoffmann-La Roche AG
Senior Device Engineer(m/w/x)
Basel
Full-timeOn-siteManagement
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 1201 F. Hoffmann-La Roche AG 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.
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121201 F. Hoffmann-La Roche AG
Senior Device Engineer(m/w/x)
Basel
Full-timeOn-siteManagement
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 1201 F. Hoffmann-La Roche AG 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
1201 F. Hoffmann-La Roche AG
Industry
Healthcare
Description
Roche is dedicated to advancing science and ensuring access to healthcare for everyone, with over 100,000 employees globally.
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