Test & Validation Engineer - Medical Devices
Core
Develop, validate, and qualify test methods and fixtures for needle-based drug delivery devices to ensure compliance with medical device regulations.
Role type
Test & Validation Engineer (Medical Devices)
Builds
Test methods, fixtures, setups, and adapters for needle-based injection systems
Domain
Medical devices / Drug delivery systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Test method development, validation and verification (V&V), force and torsion measurement, statistical analysis, medical device regulations (ISO 13485, ISO 11608), design control processes, GMP
Preferred skills
Plastics design (injection molding), 3D CAD tools (SolidWorks), mechanical design principles, tolerance analysis
Technologies
Zwick, Stable Micro Systems, JMP
Responsibilities
Develop and optimize test methods for needle-based injection systems; Design, build, and qualify test fixtures and adapters; Derive and document test cases and acceptance criteria based on product specifications; Execute engineering, feasibility, and design verification testing; Perform test method validation according to applicable standards; Generate compliant documentation (protocols, reports, validation documentation); Support test method transfer to manufacturing sites
Seniority
Mid-level, hands-on IC
