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Principal Device Engineer - Drug Delivery (Combination Products)(m/w/x)
Driving drug delivery platform tech development for subcutaneous and ocular applications. Extensive parenteral device development experience required. Integration of container closure systems and bridging formulation with mechanical performance.
Requirements
- Doctoral or master’s degree or engineering diploma
- Extensive industry experience in parenteral device development
- Knowledge in ocular delivery (ideal)
- Broad expertise in regulatory requirements and technical standards for combination product development
- Knowledge of 21 CFR Parts 4 and 820; ISO 62366; 11608; 11040 & 14971 (preferred)
- Profound understanding of device design
- Profound understanding of primary container integration
- Profound understanding of evaluation and statistics
- Strong organizational skills
- Strong communication skills
- Proven technical writing skills
- Proven documentation skills
- Excellent written communication skills in English
- Excellent verbal communication skills in English
- Applications from persons with severe disabilities warmly welcomed
- Preferential consideration for equally qualified severely disabled applicants
Tasks
- Drive technology development for drug delivery platforms
- Focus on subcutaneous and ocular applications
- Integrate container closure systems (PFS, cartridges)
- Bridge formulation requirements with mechanical performance
- Ensure system-level definition and verification
- Address complex technological challenges
- Develop benchmark solutions
- Accelerate time to market
- Contribute to the evolving device portfolio
- Serve as key point of contact in product development
- Lead cross-functional teams with internal and external stakeholders
- Provide technical guidance and risk assessment
- Support project decisions from development to launch
- Ensure robustness and lifecycle sustainability
Work Experience
- approx. 4 - 6 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
Tools & Technologies
- 21 CFR Parts 4 and 820
- ISO 62366
- 11608
- 11040
- 14971
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Principal Device Engineer - Drug Delivery (Combination Products)(m/w/x)
Driving drug delivery platform tech development for subcutaneous and ocular applications. Extensive parenteral device development experience required. Integration of container closure systems and bridging formulation with mechanical performance.
Requirements
- Doctoral or master’s degree or engineering diploma
- Extensive industry experience in parenteral device development
- Knowledge in ocular delivery (ideal)
- Broad expertise in regulatory requirements and technical standards for combination product development
- Knowledge of 21 CFR Parts 4 and 820; ISO 62366; 11608; 11040 & 14971 (preferred)
- Profound understanding of device design
- Profound understanding of primary container integration
- Profound understanding of evaluation and statistics
- Strong organizational skills
- Strong communication skills
- Proven technical writing skills
- Proven documentation skills
- Excellent written communication skills in English
- Excellent verbal communication skills in English
- Applications from persons with severe disabilities warmly welcomed
- Preferential consideration for equally qualified severely disabled applicants
Tasks
- Drive technology development for drug delivery platforms
- Focus on subcutaneous and ocular applications
- Integrate container closure systems (PFS, cartridges)
- Bridge formulation requirements with mechanical performance
- Ensure system-level definition and verification
- Address complex technological challenges
- Develop benchmark solutions
- Accelerate time to market
- Contribute to the evolving device portfolio
- Serve as key point of contact in product development
- Lead cross-functional teams with internal and external stakeholders
- Provide technical guidance and risk assessment
- Support project decisions from development to launch
- Ensure robustness and lifecycle sustainability
Work Experience
- approx. 4 - 6 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
Tools & Technologies
- 21 CFR Parts 4 and 820
- ISO 62366
- 11608
- 11040
- 14971
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Boehringer Ingelheim
Industry
Pharmaceuticals
Description
The company is focused on delivering lasting value to patients through innovative therapies and early clinical development.
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