Senior Expert Engineering – Medical Device Development
Core
Developing a new auto-injector platform from early phase to market launch for drug delivery devices.
Role type
Senior Design Engineer (Medical Devices)
Builds
Drug device combination products (auto-injectors)
Domain
Healthcare / Medical Devices / Mechanical Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
mechanical engineering, plastic and metal component design, tolerance analysis, metrology, lab testing, material qualification, design for manufacturing and assembly, regulatory standards knowledge, Design History File documentation
Preferred skills
cross-functional team interaction in matrix organizations
Technologies
CAD, 3D modeling
Responsibilities
Work on platform device development and participate in cross-functional project activities; Contribute to the complete development process including ideation, prototyping, piloting, manufacturing, and complaint handling; Create and review IP; Work with third-party suppliers including prototypers, tool makers, and CMOs; Manage testing and characterization for acceptance, compliance, and performance; Perform root cause analysis and develop robust solutions; Ensure components are delivered and controlled for clinical trials and commercial production; Author key design history file documents including design input requirements, component specifications, and design verification documents.
