EDI Staff Engineer
Core
Design, integrate, validate, and optimize manufacturing equipment and automated systems for medical device production, ensuring compliance with regulatory standards and supporting production ramp-up.
Role type
Senior IC equipment engineering specialist (manufacturing automation)
Builds
Assembly, packaging, inspection, and manufacturing equipment; automated systems for medical device production
Domain
Medical technology / Manufacturing engineering
Deliverable
physical/clinical work
Required skills
Mechanical engineering, equipment design, process validation, risk assessment (FMEA), supplier management, project management, Lean Manufacturing, data analysis, problem solving
Preferred skills
SolidWorks, 3D modeling, capital budget management, leadership in project delivery
Technologies
SolidWorks, 3D modeling software
Responsibilities
Support design and development of manufacturing equipment including mechanical, electrical, and control elements; Execute process verification, validation, and production ramp-up activities; Lead continuous improvement and Lean Manufacturing initiatives; Troubleshoot equipment systems and process issues; Coordinate with suppliers and system integrators for RFQs and technical evaluations; Ensure compliance with EHS, ISO, FDA, and GMP requirements
Seniority
Senior, hands-on IC