FDA-Regulated Medical Device Packaging Engineer (Contract)

MillenniumSoft Inc; Covington (GA); Presencial; USD 62.000 - 83.000; Jornada completa

Descripción de la vacante

MillenniumSoft Inc. in Covington, GA seeks a Packaging Engineer with FDA regulatory focus and packaging engineering experience.

The contract role runs 12 months, 40 hours/week, first shift, with W2 employment for US citizens or GC holders. Responsibilities include validating package designs, selecting compliant materials, and converting regulatory needs into designs; includes prototype development and documentation per policy.

Formación

• BS in Packaging Engineering or related field
• Minimum 2 years’ experience or relevant experience
• Regulated industry experience a plus
• Microsoft Word, Excel, Project, PowerPoint, and Access

Responsabilidades

• Validation and testing of commercial package design and any modifications to existing package design.
• Recommends appropriate packaging equipment, tooling, and/or materials to meet regulatory requirement for package testing.
• Converts customer/regulatory needs into existing package design.
• Develops prototypes of concepts and subcomponent mechanisms.
• Designs/re-designs and develops tooling and fixturing required to support existing or package design/re-design.
• Utilizes design concepts and analysis techniques, including Failure Mode Analysis, Finite Element Analysis and modeling, Geometric Dimensioning, Statistical Analysis, and Tolerancing Analysis.
• Works with vendors and customers to identify appropriate materials and components to meet packaging requirements.
• Analyzes existing design to ensure that the specifications meet the customers’ and regulatory requirement.
• Detail re-designs to ensure manufacturability; dimensioning and tolerances stack-up analysis.
• Establishes and maintains appropriate documentation of activities in accordance with policies and procedures.
• Actively participates on MDR project team meetings and/or Design Reviews.

Conocimientos

Packaging design

Regulatory knowledge

Educación

BS in Packaging Engineering

Herramientas

Microsoft Word

Excel

PowerPoint

Access

Microsoft Project

Descripción del empleo

MillenniumSoft Inc. in Covington, GA seeks a Packaging Engineer with FDA regulatory focus and packaging engineering experience.

The contract role runs 12 months, 40 hours/week, first shift, with W2 employment for US citizens or GC holders. Responsibilities include validating package designs, selecting compliant materials, and converting regulatory needs into designs; includes prototype development and documentation per policy.