Advanced Manufacturing Engineer (AME)

Job Title : Sr. Advanced Manufacturing Engineer (AME)

Location : El Paso, Texas

Bi-Lingual candidate- English & Spanish

Job Description

Coordinates and Supports Suppliers for Manufacturing of Custom Equipment / Tooling

Coordinates purchase and delivery of Equipment / Tooling

Coordinates installation of Equipment / Tooling

Develops and Executes IQ and OQ Protocols and Reports

Develops and Executes Test Method Validations / Gage R&R

Generates and Issues for Approval SOPs and Manufacturing Procedures

Develops and Executes Component Qualifications

Develops and Executes PQ and PPQ Protocols and Reports

Develops Manufacturing Capacity Analysis

Develops and Executes Process Characterizations / Design of Experiments (DOE)

Develops documentation / justification for assigned capital projects

Complies with cGMP's, Quality Standards , and established policies and procedures

Executes other duties assigned by his supervisor

Education and / or Experience :

Bachelor's Degree in Engineering

Experience in the Medical Device / Pharmaceutical Industries : Yes

5+ years of experience in the following fields :

Manufacturing

New Product Transfers

Product / Process Development