Senior Engineer, Device Technical Operations (Hybrid)

Role: Senior Engineer - Device Technical Operations, supporting development, scale-up, and commercialization of medical devices and combination products, including autoinjectors, ophthalmic, and inhalation therapies. Responsibilities: lead design controls, design transfer, risk management, verification testing, and process validation; manage internal and external manufacturing; support regulatory agency interactions, including inspections; develop strategic technology transfer plans; collaborate with manufacturing sites and cross-functional teams to ensure product robustness, compliance, and quality. Requirements: bachelor’s degree in mechanical or biomedical engineering (advanced degree preferred); 5+ years in pharmaceutical, biologic, or device engineering, with at least 2 years supporting commercial manufacturing; expertise in design controls, risk analysis, process validation, and manufacturing operations such as injection molding, automation, and assembly. Preferred: experience with autoinjectors, ophthalmic, or inhalation products. High-Value: medical device/modality expertise, combination products, regulated environments compliant with ISO 13485 and ISO 14971, GxP, and lifecycle management. Collaboration: cross-functional with internal teams and external manufacturing partners. WorkSetup: hybrid with 10% travel.