Packaging Engineer (Must Have EUMDR, Design Control)
About The Position
The Packaging Engineer will be responsible for packaging design development, verification, and validation for medical devices or the pharmaceutical industry. This role requires a strong understanding of design control processes, CAD tools for packaging design, and packaging standards and regulatory requirements, specifically EUMDR and ISO 11607. The engineer will work as part of a global team and will apply packaging engineering principles to design, prototype, evaluate, and improve packaging concepts. The position involves identifying, analyzing, and specifying packaging materials and equipment, and supporting external resources as needed. The role requires effective communication of technical knowledge and validation of understanding of various packaging test methods and standards.
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
- Working knowledge of package engineering principles and techniques
- Working knowledge of legal requirements and documents.
- 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
- Must have EUMDR knowledge
- Must have Design Control knowledge
- US Citizens or GC Holders Only
Nice To Haves
- Medical device packaging system development for flexible and rigid packaging applications.
- Packaging system verification and validation experience
Responsibilities
- Packaging design development for medical devices or pharma industry
- Packaging verification and validation for medical devices or pharma industry
- Design control process for medical devices
- Utilize CAD tools for packaging design
- Adhere to packaging standards and regulatory requirements for medical devices (i.e. ISO11607, EUMDR, etc.)
- 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.
- Conducts packaging system verification and validation.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
