Staff Equipment and Automation Engineer - 1st shift
Core
Technical subject matter expert leading new product introductions, design transfers, and improvements for manufacturing equipment and automation systems in a GMP environment.
Role type
Staff Equipment and Automation Engineer
Builds
New manufacturing equipment, automation systems, and production processes for cancer diagnostics
Domain
Life sciences / Medical devices / Diagnostics
Required skills
Project management, cross-functional leadership, equipment specification and integration, design for manufacturability, risk assessment, GMP compliance, troubleshooting, documentation, data analysis
Preferred skills
Biological systems integration, FDA/cGMP/CAP/CLIA regulated environment experience, Electronic Quality Management Systems (Agile), Manufacturing Software Systems (SAP)
Technologies
SAP, Electronic Quality Management Systems
Responsibilities
Lead new product introductions and design transfers from R&D to production; Develop processes and procedures for new equipment; Manage cross-functional teams for complex projects; Perform risk assessments and design reviews; Support equipment setup, adjustment, troubleshooting, and maintenance; Create regulatory documentation; Mentor junior engineers; Lead investigations of manufacturing processes
Seniority
Staff, hands-on IC with strategic project leadership