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.

• 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 ISO
  14971 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.