Packaging Engineer

Millenniumsoft•Covington, GA

7d•Onsite

About The Position

We are seeking a Packaging Engineer with 2-3 years of experience in the packaging engineering field, specifically within a regulated industry like medical devices. The role involves assessing current packaging designs to ensure compliance with new EU MDR regulations (ISO 11607) and conducting ship testing using ASTM and ISTA methods. You will be responsible for redesigning packaging as needed, working with suppliers and manufacturing to ensure feasibility and capability, and developing prototypes. This position requires a strong quality and regulatory mindset, with the ability to convert customer and regulatory needs into practical packaging solutions. You will also be involved in writing test protocols, performing various analyses (Failure Mode, Finite Element, Geometric Dimensioning, Statistical, Tolerancing, Stress/Strain), and collaborating with vendors and customers on material selection. Detailed documentation of activities in accordance with company and regulatory policies is essential, and active participation in MDR project team meetings and Design Reviews is expected.

Requirements

2-3 years of experience in packaging engineering.
Must have FDA regulatory experience.
Experience with EU MDR regulations.
Quality mindset.
Understanding of converter processes for feasibility by suppliers and manufacturing process capabilities for validation protocols.
Ability to assess current packaging design to meet EU regulations for ISO 11607.
Experience with ship testing using ASTM and ISTA methods.
Must understand package design, packaging optimization and value chain.
Experience writing test protocols.
Proficiency in drawing software: CAPE/TOPS, AutoCAD/ArtiosCAD, Solidworks.
Knowledge of materials: flexible sterile barrier films, rigid thermoformed parts, carton, corrugate, PS labels and printed inserts.
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.
BS in Packaging Engineering or related field of study.
Minimum 2 years experience or relevant experience.
AutoCad/Drawing experience.

Nice To Haves

Regulated industry experience a plus.

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 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.