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Duties:
- The Client Device Development & Technology (DD&T) Team is seeking a hands-on/ lab-focused Scientist focused on the characterization and testing of devices (components, sub-assemblies, and full devices) and combination products (drug-delivery products).
- This position will be responsible for technical interrogation of the various drug delivery device technology platforms supporting Client's pipeline to identify risks (i.e. when/why/how will the device fail) and opportunities for improvement.
- They will utilize a wide variety of cutting-edge analytical instruments, methods, and extensive data analysis/interpretation to build fundamental understanding of the device's material and functional properties and attributes.
- Many of the drug delivery device technology platforms are often assemblages of injection molded plastic components driving delivery of a drug, typically though mechanical (i.e. compress/torsion spring, compressed gas) or electro-mechanical (i.e. DC motor and battery driving a gearbox) means. Examples include, but not limited to, injector pens, on-body injectors, and inhalers. At this early stage of evaluation material is often limited and will demand creative approaches.
Qualifications:
- B.S. or M.S. degree and 1+ years of design, engineering, and mechanical testing/test method development experience (3+ years for Level II role).
- Exceptional mechanical testing and troubleshooting skills able to work independently in a laboratory setting.
- Deep technical understanding of test method development and qualification/validation techniques.
- Fluency with mechanical testing, imaging, and measurement equipment and techniques. Including, but not limited to, force/tension/compression testing, rheometry, and microscopy.
- Excellent collaboration, ideation, and prototyping skills, including fixture development for functional testing.
- Experience in 3D CAD (e.g. SolidWorks), geometric tolerancing and stack-up analysis.
- Strong documentation skills (following Good Documentation Practices) and ability to analyze test cases and provide comprehensive feedback and recommendations for product or design changes.