Job Description :
Title : Fixture design & test method validation engineer (Medical Devices)

Location : Temecula, California

Duration : 6 months

Number of position : 1

Primary Skills : Manufacturing experience in Medical Devices,especially disposable Cardio-Vascular products.,Experience in CTQs assessment and translating CTQ into manufacturing specifications,Experience in performing gap assessments between design outputs and manufacturing specifications,Design and develop tooling,and fixtures using Solid works

Description:

Job Title: Fixture design & test method validation engineer (Medical Devices)

Location: Temecula, California -92591

Hiring Type: Contract

Duration: 6 Months plus

Required Skills and Experience:

1.Manufacturing experience in Medical Devices, especially disposable Cardio-Vascular products.

2.Experience in CTQs assessment and translating CTQ into manufacturing specifications

3.Experience in performing gap assessments between design outputs and manufacturing specifications

4.Design and develop tooling, and fixtures using Solidworks

5.Process Validation – Installation Qualification (IQ), Operational Qualification (OQ) & Performance Qualification (PQ)

6.Experience in performing process characterization studies / Design of Experiments (DOE) to establish the process window / range for all the influencing process parameters

7.Experience in Test Method Validation (TMV) & Inspection Method Validation (IMV)

8.Utilization of tools like Gage R&R, Cp, Cpk, and Statistical Process Control (SPC) to improve manufacturing processes.
             

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