Senior Manufacturing Lead - Temecula, CA

Role: Senior Manufacturing Lead
Location: Temecula, CA
Duration: 6+ Months
BGV will be done for the selected candidates.
1) Manufacturing experience in Medical Devices, especially disposable Cardio-Vascular products.
2) Six Sigma certified (Black Belt)
3) Experience in CTQs assessment and translating CTQ into manufacturing specifications
4) Experience in performing gap assessments between design outputs and manufacturing specifications
5) Design and develop manufacturing processes, tooling, and fixtures in order to meet production needs, while enhancing productivity and product quality
6) Process Validation – Installation Qualification (IQ), Operational Qualification (OQ) & Performance Qualification (PQ)
7) Experience in performing process characterization studies / Design of Experiments (DOE) to establish the process window / range for all the influencing process parameters
8) Experience in Test Method Validation (TMV) & Inspection Method Validation (IMV)
9) Utilization of tools like Gage R&R, Cp, Cpk, and Statistical Process Control (SPC) to improve manufacturing processes
10) Good experience in Lean manufacturing.

Understanding of manufacturing concepts like Value Stream mapping, 5S and Visual Workplace to improve quality, labor efficiency, and throughput.
11) Experience in Manufacturing process improvements / Manufacturing yield improvements to improve product quality
12) Good knowledge in Statistics & Minitab
13) Experience in Product Risk Management as per ISO14971 with good knowledge in executing PFMEA
14) Experience in handling CAPA (including field failure / root cause investigation), SCAR and NCMRs
Six Sigma (Green belt), Medical Device, Manufacturing, Cardio-vascular, catheter, Process validation, Test Method validation, GD&T, Tolerance analysis, Jigs & Fixture design, Statistics, Minitab, Poka-Yoke, Process development, Process improvement, Value Stream mapping
Mandatory Skills
Technical / Soft Skills
Expertise Level (Expert / Good / Knowledge)
Remarks
Poka-Yoke
Expert
-
Process improvement
Good
-
GD&T
Good
-
Tolerance analysis
Good
-
Test Method validation
Good
-
Process validation
Good
-
Cardio-vascular catheter manufacturing process
Good
Desired Skills
Technical / Soft Skills
Expertise Level (Expert / Good / Knowledge)
Remarks
Process development
Good
-
Value Stream mapping
Good
-
PFMEA
Good
-
Please respond with your word resume and requested details:
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All your information will be kept confidential according to EEO guidelines.