Associate Principal Scientist/Engineer, Medical Device and Combination Products, ISO/DV Testing Manager
Core
Manage and oversee formal medical device method validation, transfer, and design verification testing in ISO-certified laboratories to support commercial product packaging and drug-delivery devices.
Role type
Associate Principal Scientist/Engineer (Medical Device Testing & Validation)
Builds
Design verification data and validated analytical methods for auto-injectors, pre-filled syringes, and other medical devices.
Domain
Medical Devices / Analytical Science / Mechanical Testing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mechanical testing, Analytical method development, cGMP/ISO 13485 compliance, Laboratory management, Design verification strategy, Technical coaching
Preferred skills
Device characterization, Container closure integrity testing, Dimensioning, Tensile/compression/torsional testing, Optical microscopy, Dye ingress testing
Technologies
Optical comparator, X-ray microscopy, Tensile testers, Compression testers, Torsional testers
Responsibilities
Manage design verification testing timelines, oversee method development and validation, ensure regulatory compliance, drive new instrumentation implementation, coach laboratory analysts
Seniority
Senior, hands-on IC with management responsibilities
