Device Equipment Engineer
Core
Technical owner for assigned equipment workstreams, responsible for specification development, supplier engagement, commissioning, qualification, and transfer activities from concept through implementation for medical devices and combination products.
Role type
Mid-level IC device equipment engineer
Builds
Manufacturing equipment and associated systems for device programs
Domain
Healthcare / Medical Devices / Pharmaceutical Manufacturing
Required skills
Equipment specification development, Supplier engagement, Commissioning, Qualification (IQ/OQ/PQ), Technology transfer, Process characterization, Risk assessment (FMEA), Engineering documentation, Cross-functional collaboration, Project execution
Preferred skills
Packaging development, AutoDesk, Microsoft Project, GAMP5 principles, CMO coordination
Technologies
AutoDesk, Microsoft Project
Responsibilities
Develop and implement engineering solutions meeting product and process requirements; Execute equipment commissioning, qualification, and verification activities; Lead technical project execution with external suppliers and CMOs; Support cross-functional project teams to execute engineering systems objectives; Provide technical input and engineering documentation including protocols and risk assessments; Support engineering risk assessments, troubleshooting, and investigations; Support technology transfer, site integration, and lifecycle activities; Support engineering operations including budget forecasting and performance monitoring.
Seniority
Mid-level, hands-on IC