Packaging Engineer

4 weeks ago


Franklin Lakes, United States Stellar Consulting Solutions, LLC Full time

Description:

Manager update:

1. Packaging design development for medical devices or pharma industry

2. Packaging verification and validation for medical devices or pharma industry

3. Design control process for medical devices

4. Packaging standards and regulatory requirements for medical devices (i.e. ISO11607, EUMDR, etc.)

Qualification: Bachelor Degree equivalent in Packaging, Mechanical Engineering, Materials Engineering or in a related field of study.

Experience: Minimum 3 years of experience in Medical Device packaging

Principal Accountabilities:

• Demonstrates working knowledge of package engineering principles and techniques.

• Demonstrates working knowledge of legal requirements and documents.

• 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.

• Has developed knowledge and skills in packaging; still acquiring / expanding fundamental knowledge and higher-level skills.

• Applies knowledge and skills to a variety of standard activities.

• Works with moderate guidance in own area of knowledge.

Special Skills:

• Effectively communicates technical knowledge and validates understanding of other packaging test methods/standards and related equipment.

• Medical device packaging system development for flexible and rigid packaging applications.

• Packaging system verification and validation experience

• Experience/knowledge with CAD tools for packaging design.

• Experience with statistics and design of experiments.

• Knowledge of the following standards: ISO 11607, ISO 13485, ISO 14971

Accountability:

• Will not manage any direct reports.

• Will not be responsible for any functional areas.


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