Engineer, Manufacturing
Core
Design, develop, and improve manufacturing processes and capabilities for reagent and collection kits, packaging components, and automation projects in a GMP-regulated environment.
Role type
Manufacturing Engineer (Entry to Mid-level)
Builds
Manufacturing processes, packaging solutions, and automation-related projects for diagnostics products
Domain
Healthcare / Medical Diagnostics / Manufacturing
Required skills
Engineering principles, problem-solving, data analysis, project execution, technical writing, documentation management, troubleshooting, process improvement, compliance with GMP
Preferred skills
cGMP knowledge, ISO 13485 familiarity, CAD, statistical tools, Lean/Six Sigma, root cause analysis, validation experience
Technologies
CAD, statistical tools, manufacturing systems
Responsibilities
Support cross-functional engineering activities and technical projects; assist with specification, procurement, and implementation of engineering controls; identify process efficiency and quality improvement opportunities; create and maintain documentation (SOPs, design specs, test records); participate in investigations, CAPA, and audits; support continuous improvement efforts.
Seniority
Junior to Mid-level, hands-on IC