Senior Engineer, Device Technical Operations (Hybrid)
Core
Senior engineering role managing internal and external manufacturing for medical devices and combination products, focusing on complex drug-delivery systems like autoinjectors, ophthalmic products, and inhalation products.
Role type
Senior IC device technical operations engineer
Builds
Medical devices and combination products for global commercialization
Domain
Medical devices / Pharmaceutical manufacturing
Required skills
Design controls, Design transfer, Control strategies, Device risk management, Design verification testing, Root cause analysis, Process validation, Injection molding, Automation, Complex assembly, Packaging operations, GMP documentation, Materials science, Mechanical engineering
Preferred skills
Autoinjector experience, Ophthalmic product experience, Inhalation product experience, Master's or PhD degree
Technologies
ISO 13485, ISO 14971-2019, Quality management systems
Responsibilities
Develop value-added solutions for medical devices, Support internal and external component manufacturing, Identify issues and provide root cause solutions, Build design engineering mindset for lifecycle management, Optimize design and manufacturing, Support regulatory agency questions and inspections, Develop strategic plans for technology transfer, Build strategic partnerships with manufacturing sites
Seniority
Senior, hands-on IC
