Packaging Validation Engineer

3 weeks ago


Grand Rapids, United States Compliance Group Inc Full time

Title: Medical Device Packaging Engineer

Location: Grand Rapids, MI (Fully onsite)

Type: W2 contract

Technical skills that you are required for this role:

Experience in medical device packaging systems and packaging process validations IQ/OQ/PQ

Advanced understanding of packaging requirements and standards I.E. ISO 11607-1 and 11607-2, ISO 13485.

Experience in CAPA, support, develop and execute remediation plans.

Education Required: Bachelor of Science Degree in Packaging Science, Mechanical Engineering, or similar discipline

Years Experience Required: Minimum of 5 years in medical device or pharmaceutical industry in Packaging or Quality Engineering

The product line will support: Cardiac Surgery

Job Responsibilities:

Designs, develops, and tests a wide variety of containers used for the protection, display, and handling of products.

Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering.

Designs package exteriors considering such factors as product identification, sales appeal, aesthetic quality, printing, and production techniques.

Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices (GMPs) and may support prototype line development in manufacturing facilities/plants.


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