Senior Manufacturing Engineer
Core
Senior Manufacturing Engineer responsible for process equipment commissioning, documentation development, and process improvement to meet quality, output, and cost goals in a medical technology environment.
Role type
Senior Manufacturing Engineer (Process & Equipment)
Builds
Manufacturing processes, equipment, and documentation for commercial medical products
Domain
Medical Technology / Manufacturing Engineering
Required skills
Process equipment commissioning, Manufacturing documentation, Process improvement, Quality compliance, Project management, Cross-functional collaboration, Problem solving, Capacity planning, Vendor qualification, Calibration management
Preferred skills
BSC systems expertise, International travel, Leadership of technical teams
Technologies
CGMP, BOMs, NCEP, CAPA, BSC systems
Responsibilities
Identify and commission key process equipment to CGMP standards; Develop and modify manufacturing documentation and procedures for new and commercial products; Improve product and process quality and output; Perform product/process/vendor qualification activities; Support material discrepancy review and disposition activities; Eliminate/reduce product/process defects and improve yields; Train cross-functional team members including engineers and technicians; Maintain valid capacity models and conduct advance planning for capital; Provide equipment calibration services and manage calibration standards.
Seniority
Senior, hands-on IC with leadership responsibilities