EDI Engineer 3
Core
Support Automation and Equipment Design and Process Implementation across the MDS business, integrating manufacturing equipment and automation solutions at production sites.
Role type
Junior IC equipment engineering specialist (manufacturing automation)
Builds
Assembly, packaging, automation, inspection, and manufacturing equipment
Domain
Medical device manufacturing / Industrial automation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
mechanical engineering principles, electrical systems knowledge, control systems basics, User Requirement Specifications (URS) development, risk assessment, FMEA, Design of Experiments (DOE), validation protocols, supplier coordination, Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), process verification, production ramp-up support, Lean Manufacturing, capital project support, documentation creation, training delivery, compliance with GMP/ISO/FDA standards
Preferred skills
SolidWorks or 3D modeling software, project management, data analysis, problem-solving methodologies, Lean leadership experience, capital budget management
Technologies
SolidWorks, 3D modeling software, manufacturing execution systems, validation software
Responsibilities
Support design and development of assembly, packaging, automation, inspection, and manufacturing equipment including mechanical, electrical, and control elements; Support preparation, maintenance, and execution of User Requirement Specifications (URS); Participate in design reviews, machine safety reviews, risk assessments, and FMEA activities; Support execution of equipment installation plans and site readiness activities; Support execution of qualification, process verification, and process validation activities; Support vertical start-up and production ramp-up activities; Support creation and handover of equipment documentation including specifications, drawings, FAT/SAT, validation, maintenance and control plans; Support training of site personnel on new equipment and processes; Support ensuring compliance with EHS, machine safety, ISO, FDA, GMP, and BD Quality System requirements
Seniority
Junior, hands-on IC