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Medical Device Platform Design Engineer(m/w/x)
Designing Autoinjector and PFS-Needle Safety Device platforms for drug delivery systems. In-depth prefilled syringe and novel drug delivery design knowledge required. Company car for private use, 6 weeks vacation.
Requirements
- BS in Mechanical Engineering or equivalent technical degree
- In-depth understanding of prefilled syringes
- In-depth understanding of Autoinjector
- In-depth understanding of PFS-Needle Safety Device
- In-depth understanding of novel drug delivery design
- In-depth understanding of novel drug delivery manufacturing processes
- Familiarity with materials science
- Knowledge of damage mechanisms in drug delivery systems
- Knowledge of common defects in drug delivery systems
- Knowledge of performance testing in drug delivery systems
- Working knowledge of system modeling tools
- Working knowledge of system modeling methodologies
- Proficiency with SolidWorks
- Proficiency with other 3D CAD modeling software
- Proven track record of technical leadership
- Proven track record of problem-solving in regulated environment
- Excellent communication skills
- Excellent interpersonal skills
- Excellent collaboration skills
- Ability to effectively engage with cross-functional teams
- Ability to effectively engage with external suppliers
- Ability to effectively engage with industry partners
- Entrepreneurial spirit
- Hands-on, roll-up-your-sleeves approach
- High sense of urgency
- Dedication to drive for results
Tasks
- Design and maintain Autoinjector and PFS-Needle Safety Device platforms
- Support product development and sustaining engineering teams
- Provide mechanical engineering design expertise
- Generate concepts and perform engineering analysis
- Develop internally and externally utilized device design platform technologies
- Provide technical oversight to external suppliers and partners
- Drive performance, accountability, and innovation in mechanical design
- Lead reliability engineering assessments
- Conduct edge-of-failure testing
- Manage variance activities
- Perform tolerance sensitivity assessments
- Create and maintain Computer Aided Engineering models
- Develop digital twins for virtual analytical data collection
- Solve functional and assembly related technical challenges
- Lead technical investigations at third-party manufacturers
- Resolve device and assembly issues
- Lead writing of product and customer requirements
- Lead design and design phase reviews
- Lead product and process risk assessments
- Lead root cause investigations
- Lead corrective action planning
Work Experience
- approx. 1 - 4 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- prefilled syringes
- Autoinjector
- PFS-Needle Safety Device
- novel drug delivery
- materials science
- Digital Twins
- CAE
- FEA
- MiniTab
- SolidWorks
- 3D CAD
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- RocheFull-timeOn-siteSeniorBasel
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Principal Design Engineer(m/w/x)
Full-timeOn-siteSeniorBasel
Medical Device Platform Design Engineer(m/w/x)
Designing Autoinjector and PFS-Needle Safety Device platforms for drug delivery systems. In-depth prefilled syringe and novel drug delivery design knowledge required. Company car for private use, 6 weeks vacation.
Requirements
- BS in Mechanical Engineering or equivalent technical degree
- In-depth understanding of prefilled syringes
- In-depth understanding of Autoinjector
- In-depth understanding of PFS-Needle Safety Device
- In-depth understanding of novel drug delivery design
- In-depth understanding of novel drug delivery manufacturing processes
- Familiarity with materials science
- Knowledge of damage mechanisms in drug delivery systems
- Knowledge of common defects in drug delivery systems
- Knowledge of performance testing in drug delivery systems
- Working knowledge of system modeling tools
- Working knowledge of system modeling methodologies
- Proficiency with SolidWorks
- Proficiency with other 3D CAD modeling software
- Proven track record of technical leadership
- Proven track record of problem-solving in regulated environment
- Excellent communication skills
- Excellent interpersonal skills
- Excellent collaboration skills
- Ability to effectively engage with cross-functional teams
- Ability to effectively engage with external suppliers
- Ability to effectively engage with industry partners
- Entrepreneurial spirit
- Hands-on, roll-up-your-sleeves approach
- High sense of urgency
- Dedication to drive for results
Tasks
- Design and maintain Autoinjector and PFS-Needle Safety Device platforms
- Support product development and sustaining engineering teams
- Provide mechanical engineering design expertise
- Generate concepts and perform engineering analysis
- Develop internally and externally utilized device design platform technologies
- Provide technical oversight to external suppliers and partners
- Drive performance, accountability, and innovation in mechanical design
- Lead reliability engineering assessments
- Conduct edge-of-failure testing
- Manage variance activities
- Perform tolerance sensitivity assessments
- Create and maintain Computer Aided Engineering models
- Develop digital twins for virtual analytical data collection
- Solve functional and assembly related technical challenges
- Lead technical investigations at third-party manufacturers
- Resolve device and assembly issues
- Lead writing of product and customer requirements
- Lead design and design phase reviews
- Lead product and process risk assessments
- Lead root cause investigations
- Lead corrective action planning
Work Experience
- approx. 1 - 4 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- prefilled syringes
- Autoinjector
- PFS-Needle Safety Device
- novel drug delivery
- materials science
- Digital Twins
- CAE
- FEA
- MiniTab
- SolidWorks
- 3D CAD
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Roche
Industry
Pharmaceuticals
Description
The company is dedicated to advancing science and ensuring access to healthcare for everyone.
Not a perfect match?
- Roche
Medical Device Platform Technical Lead(m/w/x)
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Medical Device Platform Lead - Autoinjector(m/w/x)
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Senior Device Engineer with Pen- / Autoinjector expertise(m/w/x)
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Principal Design Engineer(m/w/x)
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