Process Engineer
Core
Lead engineering changes and qualify manufacturing processes for medical device production on the floor and at subcontractors.
Role type
Manufacturing Process Engineer
Builds
Medical device production lines and components
Domain
Medical Devices / Manufacturing Engineering
Required skills
Engineering change management, process verification and validation, root cause analysis, injection molding support, stakeholder management, data analysis, hands-on production support
Preferred skills
FDA/ISO 13485 regulatory knowledge, Lean Manufacturing, SolidWorks, eQMS systems, overseas supplier qualification
Technologies
Injection molding, sheet metal, machining, Microsoft Excel (via careerplan.io/jobs/C6-00F-85-275-process-engineer)
Responsibilities
Lead end-to-end engineering changes (ECOs), execute IQ/OQ/PQ protocols, support injection molding activities, conduct technical investigations and root cause analysis, optimize manufacturing processes based on yield data
Seniority
Mid-level, hands-on IC
