Packaging Engineer (Medical Device packaging)

Millenniumsoft•Franklin Lakes, NJ

3d•Onsite

About The Position

This position is located in Franklin Lakes, New jersey. This is an on-site role. The Packaging Engineer will demonstrate working knowledge of package engineering principles and techniques, as well as legal requirements and documents. They will design, prototype, and qualify standard new packaging concepts in accordance with design control requirements with moderate guidance. The role also involves evaluating and improving standard existing packaging concepts, identifying, analyzing, and specifying standard packaging materials and equipment with moderate guidance, and supporting external resources/contractors as required. The engineer will apply knowledge and skills to a variety of standard activities and work with moderate guidance in their area of knowledge. This role does not involve managing direct reports or functional areas.

Requirements

Bachelor Degree equivalent in Packaging, Mechanical Engineering, Materials Engineering or in a related field of study.
Minimum 2 years of experience in Medical Device packaging.
CAD: Ability to modify and generate drawings in SolidWorks.
Lab equipment knowledge: Ability to use sealing equipment, dispensing equipment, basic tools.
Experience in test method validations.
Experience in root cause analysis methodologies.
Experience in statistical tools using Minitab to design DOE’s, data analysis such as normality, tolerance intervals, regressions.
Experience with prototyping and ability to use equipment like a flow wrapper.
Experience in Med devices in design verification.
Documentation: Proficient in writing protocols and reports.
Knowledge of the following standards: ISO 11607, ISO 13485, ISO 14971.

Nice To Haves

Experience/knowledge with CAD tools for packaging design.
Experience with statistics and design of experiments.

Responsibilities

Designs, prototypes and qualifies standard new packaging concepts in accordance with design control requirements with moderate guidance.
Evaluates and improves standard existing packaging concepts with moderate guidance.
Identifies, analyzes and specifies standard packaging materials and equipment with moderate guidance.
Supports external resource/contractors as required.
Effectively communicates technical knowledge and validates understanding of other packaging test methods/standards and related equipment.
Develops medical device packaging systems for flexible and rigid packaging applications.
Performs packaging system verification and validation.