Senior Manufacturing Lead - Temecula, CA

Company Description IT

Job Description

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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Additional Information All your information will be kept confidential according to EEO guidelines.