Advanced Manufacturing Engineer (AME)

Position Overview

The Sr. Advanced Manufacturing Engineer (AME) position is based in El Paso, Texas and requires a Bi-Lingual candidate – English & Spanish. This role is responsible for coordinating and supporting suppliers in the manufacturing of custom equipment/tooling, managing equipment purchase, delivery, and installation, as well as developing and executing various manufacturing protocols and reports while ensuring compliance with cGMP’s and quality standards.

Key Responsibilities

• 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 as assigned by the supervisor

Required Qualifications

• Bachelor’s Degree in Engineering
• Experience in the Medical Device / Pharmaceutical Industries
• 5+ years of experience in manufacturing, new product transfers, and product/process development