Combination Product Characterization and Verification (CPCV) Team seeks a hands-on device characterization and design-focused scientist.
Responsibilities:
- Technically interrogate drug delivery device technology platforms to identify failure risks and improvement opportunities.
- Use cutting-edge analytical instruments/methodologies (including in silico modeling) to understand device material and functional properties.
- Focus on pre-filled syringe and auto-injector combination product development.
- Collaborate cross-functionally; provide scientific leadership and strong written/oral communication.
Education (minimum):
- B.S., M.S., or Ph.D. in Mechanical Engineering, Material Science, or equivalent.
Required experience/skills:
- Ph.D. + 4 years; or M.S. + 4 years; or B.S. + 6 years in design, engineering, and testing/test method development.
- Independent lab testing/troubleshooting.
- Optical imaging and mechanical testing: advanced imaging, tensile/compression, surface characterization, X-ray CT, rheometry, microscopy.
- Collaboration/ideation/prototyping: brainstorming, proof of concept, prototypes, functional testing.
- 3D CAD (e.g., Solidworks), geometric tolerancing and stack-up analysis.
- FMEA/DFMEA fluency.
- Cross-functional communication and liaising with QA, Analytical Sciences, CROs, etc.
- Experience in risk-oriented, regulated environments; lead development projects and manage external vendors/manufacturers.
Preferred:
- Medical device development knowledge and Design Controls (21 CFR 820.30).
- Standards: ISO 13485, ISO 14971, EU MDR, EN 60601, IEC 62304, ISO 11608; plus familiarity with 21 CFR Part 4, 21 CFR 211, FDA Container Closure guidance, ISO 11040, ISO 10993.