Senior Manufacturing Lead - Temecula, CA

Requirements

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

• 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

• Process development: Good (-)
• Value Stream mapping: Good (-)
• PFMEA: Good (-)

How to apply

Please respond with your word resume and requested details:

Full Name Work Authorization: Contact Number : Email ID : Skype ID: Current location: Willing to relocate : Rate/hr :

Other

Company Description · IT Job Description Role: Senior Manufacturing Lead Location: Temecula, CA Duration: 6+ Months

BGV will be done for the selected candidates.

Mandatory Skills Technical / Soft Skills Expertise Level (Expert / Good / Knowledge) Remarks

Desired Skills Technical / Soft Skills Expertise Level (Expert / Good / Knowledge) Remarks