Process Engineer
Core
Lead process engineering team to ensure seamless support to the value stream, optimize machine up-time, and drive automation and continuous improvement projects.
Role type
Senior Process Engineer (Manufacturing)
Builds
Medical devices and assembly processes
Domain
Medical device manufacturing / Automation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process engineering, automation, equipment maintenance, validation, project management, capital expenditure management, risk assessment, yield improvement, OEE optimization, cGMP knowledge
Preferred skills
Assembly process design, tooling & fixtures design, FDA regulations, Medical Devices Regulation (2017/745), ISO 13485, ISO 14971, pharmaceutical industry experience
Technologies
Automation systems, assembly equipment, validation tools
Responsibilities
Lead engineering initiatives for optimal machine up-time, manage equipment maintenance and upgrades, execute continuous improvement projects, ensure compliance with quality policies and safety regulations, manage engineering resources and budget, lead validation activities
Seniority
Mid-level, hands-on IC