Senior Manufacturing Lead - Temecula, CA

Senior Manufacturing Lead - Temecula, CA Role: Senior Manufacturing Lead Location: Temecula, CA Duration: 6+ Months BGV will be done for the selected candidates. Requirements Manufacturing experience in Medical Devices, especially disposable Cardio‑Vascular products. Six Sigma certified (Black Belt). Experience in CTQs assessment and translating CTQ into manufacturing specifications. Experience in performing gap assessments between design outputs and manufacturing specifications. Design and develop manufacturing processes, tooling, and fixtures in order to meet production needs, while enhancing productivity and product quality. Process Validation – Installation Qualification (IQ), Operational Qualification (OQ) & Performance Qualification (PQ). Experience in performing process characterization studies / Design of Experiments (DOE) to establish the process window / range for all influencing process parameters. Experience in Test Method Validation (TMV) & Inspection Method Validation (IMV). Utilization of tools like Gage R&R, Cp, Cpk, and Statistical Process Control (SPC) to improve manufacturing processes. Good experience in Lean manufacturing. Understanding of manufacturing concepts such as Value Stream mapping, 5S and Visual Workplace to improve quality, labor efficiency, and throughput. Experience in Manufacturing process improvements / Yield improvements to improve product quality. Good knowledge in Statistics & Minitab. Experience in Product Risk Management as per ISO14971 with good knowledge in executing PFMEA. Experience in handling CAPA (including field failure / root cause investigation), SCAR and NCMRs. All your information will be kept confidential according to EEO guidelines. #J-18808-Ljbffr Info-Ways