Combination Products Senior Engineer
Core
Lead technical and scientific activities for drug-device combination product test method development, execution, and validation while serving as a technical contact for pharmaceutical customers.
Role type
Senior IC mechanical/biomedical engineer (combination products testing)
Builds
Validated test methods, testing equipment, and fixturing for drug delivery systems and medical devices
Domain
Medical technology / Drug-device combination products
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Test method development and validation, Fixture design and development, CAD (SolidWorks), GD&T, Statistical analysis (DOE, ANOVA), Root cause investigation, Regulatory standards knowledge (ISO 11608, 11040, 13485), Mechanical measurement equipment operation, Vision systems, Container closure integrity instrumentation
Preferred skills
Small-scale filling and component assembly, Design control and system integration, Silicone or particulate analysis, 3D printing for rapid prototyping, cGMP environment experience
Technologies
Instron, Zwick, Keyence, SolidWorks
Responsibilities
Develop and validate test methods and testing equipment for drug delivery systems, Design fixturing and create engineering drawings, Lead root cause investigation activities, Coordinate with cross-functional teams and external vendors, Develop training modules and technical documentation, Interface with machine shop for fabrication, Advise customers on technical solutions and testing services
Seniority
Senior, hands-on IC with mentorship responsibilities
