microvention inc

MicroVention, Inc. in Aliso Viejo, CA, is seeking a Design Quality Engineer to lead multiple quality initiatives and manage the Design Quality Engineering team supporting the development and manufacture of medical devices. You will guide R&D product development projects, design changes, and KTBR initiatives as the Design Quality Engineer representative in...

Supports the lean manufacturing of products for medical devices through Operational systems development, process flow, process efficiency, Lean training and mentoring, and activities that grow the Lean culture at the organization. Job duties:Improves Industrial, Industrial Engineer, Operations, Manufacturing

Terumo Neuro in Aliso Viejo, CA seeks an experienced risk management professional to review risk impact assessments and design changes for product safety and efficacy, ensuring alignment with ISO 14971, 21 CFR 820, and EU MDR.You will lead cross-functional risk analyses (PHA, FMEA), maintain risk management files, and drive continuous improvement of risk...

Responsible for reviewing risk impact assessments and design change notifications received from R&D and Operations to evaluate potential impact to product safety, effectiveness, and the applicable risk management file. Apply risk management principles across R&D, Operations, and Post-Market Surveillance. Promote existing tools and proper utilization of the...