Packaging Engineer

Position: Packaging Engineer

Location: Covington, GA

Duration: 12+ Months Contract

Total Hours/week: 40.00
pay rate: $30-40/hr

1st Shift

Client: Medical Device Company

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

No H1B’s

LOCAL CANDIDATES PLEASE OR WILLING TO RELOCATE IMMEDIATELY
Packaging engineer field of study or experience in packaging engineering - 2 - 3 years of experience

Must have FDA regulatory experience
Please review these must haves and review with your candidate to ensure
• EUMDR position – med device regulations experience
• Quality mindset
• Regulatory – EU has come up with new regulations
• Existing products meet the new regulations
• Understanding of converter processes for feasibility by suppliers and manufacturing process capabilities for validation protocols
• Will assess current packaging design to meet the EU regulations for ISO 11607
• Ship testing with ASTM and ISTA methods.
• Must understand package design, packaging optimization and value chain – does redesign if needed.
• Writing test protocols
• Drawing software – CAPE/TOPS, AutoCAD/ArtiosCAD, Solidworks.
• Materials – flexible sterile barrier films, rigid thermoformed parts, carton, corrugate, PS labels and printed inserts.

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:
o Failure Mode Analysis
o Finite Element Analysis & modeling
o Geometric Dimensioning
o Statistical Analysis
o Tolerancing Analysis
o 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
AutoCad/Drawing experience