Senior Expert Engineering
Core
Lead the development of innovative drug-device combination products, specifically autoinjectors and novel drug delivery principles like on-body injectors and inhalers.
Role type
Senior Expert Engineering (Medical Device)
Builds
Autoinjectors, on-body injectors, inhalers, and radioligand therapy systems
Domain
Healthcare / Medical Devices / Drug Delivery
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mechanical Engineering, Biomedical Engineering, medical device development, design verification, regulatory compliance, supplier management, Design Controls, DHF documentation
Preferred skills
Cross-functional leadership, technical writing, root cause analysis, industrialization
Technologies
Design History File (DHF), Design Controls
Responsibilities
Provide technical leadership in cross-functional device development subteams; Define design input requirements and specifications; Lead design verification and characterization activities; Provide technical input to regulatory submission dossiers; Perform technical investigations and root cause analyses; Ensure development activities comply with regulations; Collaborate with external partners and suppliers; Ensure documentation supports clinical studies and commercial manufacturing.
Seniority
Senior, hands-on IC
