Beschreibung
We are looking for a
Design Test Method Validation Engineer (m/f)
Reference: -en
Start: 07/16
Duration: 8 MM
Place: in Baden-Württemberg
Branch: Herstellung von medizintechnischen Apparaten und Materialien a. n. g.
Your tasks:
- Manage an external laboratory to develop Validated Functional Test Methods which will be used to test products throughout the design phase.
- Manage external laboratories or service providers to validate internal installed test methods
- Develop protocols for development and validation of test methods consistent with company procedures.
- Review existing internal procedures on Test Method Validation to ensure compliance and suitability and if required, update the procedures.
- Manage the work of the external laboratory to ensure test methods are developed in compliance with the agreed schedule.
- Successful transfer of validated test method back into the company.
Your qualifications
- Experience in Functional Testing of Medical Devices (e.g. Blood tests, Water Leak Test, Pressure Leak Test, Tension Test, etc.), Dimensional (e.g. using Vison Measurement System (OGP), Optical Comparator, Caliper, Ruler, etc.), Visual (e.g. Visual inspection with Naked Eye, with Magnification, Vision System, etc).
- Knowledge of statistical tools related to Measurements System Analysis such as GR&R, Gage Linearity and Bias, Attribute Agreement Analysis, Kappa Statistics, Control Charts, etc.
- Knowledge and experience with Measurements System Analysis.
- Development and writing of TMV protocols and reports.
- Execution and Coordination of TMV studies (Blind Study).
- Development of Test Method Work Instructions.
Skills:
- Test engineer