Packaging Engineer (FDA Regulatory & Packaging engineer field of study or Exp in packaging 2to3 yrs

MillenniumSoft Inc; Covington (GA); On-site; USD 85,962,000 - 114,616,000; Full time

Job summary

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.

Qualifications

• 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

Responsibilities

• 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.

Skills

Packaging design

Regulatory knowledge

Education

BS in Packaging Engineering

Tools

Microsoft Word

Excel

PowerPoint

Access

Microsoft Project

Job description

Position : Packaging Engineer (FDA Regulatory & Packaging engineer field of study or Exp in packaging engineering 2to3 years of Exp)

Location : Covington, GA

Duration : 12 Months

Total Hours/week : 40.00

pay rate: $30-40/hr

1st shift

Client: Medical Device Company

Job Category: Engineering

Level Of Experience: Entry Level

Employment Type: Contract on W2 (Need US Citizens, GC Holders Only)

Job Description

• Packaging engineer field of study or experience in packaging engineering - 2 - 3 years of experience

Duties

• 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 but not limited to:
• Failure Mode Analysis
• Finite Element Analysis & modeling
• Geometric Dimensioning
• Statistical Analysis
• Tolerancing Analysis
• Stress/Strain Analysis
• Works with vendors and customers to identify appropriate materials and components to meet packaging requirements.
• Analyzes existing design to ensure that the specifications (Product Performance Specifications) meet the customers’ and/or regulatory requirement.
• Ability to detail re-designs to ensure manufacturability; proper dimensioning and tolerances stack-up analysis. Recommends modifications as required.
• Establishes and maintains appropriate documentation of activities in accordance with existing policies and procedures (Divisions, Corporate, and Regulatory compliance)
• Actively participates on MDR project team meetings and/or Design Reviews.

Basic Qualifications

• Proven ability to design/re-design existing commercial packaging
• Proficient in the use of a personal computer with intermediate keyboarding skills and proficiency in the use of Microsoft Word, Excel, PowerPoint, Access, Microsoft Project, and various statistical software packages.

Education And Qualifications

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