Senior AME – Medical Devices Process Validation

TechDigital Group; El Paso (TX); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading engineering company in El Paso is looking for a qualified individual to coordinate manufacturing processes for custom equipment and tooling. Responsibilities include supporting suppliers, executing protocols, and ensuring compliance with quality standards. Candidates must possess a Bachelor's Degree in Engineering and have over 5 years of experience in manufacturing, new product transfers, and product/process development.

Qualifications

• 5+ years of experience in Manufacturing.
• 5+ years of experience in New Product Transfers.
• 5+ years of experience in Product / Process Development.

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.
• Executes other duties assigned by his supervisor.

Education

Bachelor's Degree in Engineering

Job description

A leading engineering company in El Paso is looking for a qualified individual to coordinate manufacturing processes for custom equipment and tooling. Responsibilities include supporting suppliers, executing protocols, and ensuring compliance with quality standards. Candidates must possess a Bachelor's Degree in Engineering and have over 5 years of experience in manufacturing, new product transfers, and product/process development.