Packaging Engineer - Must Have Medical Device Exp
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 the design control process and relevant packaging standards and regulatory requirements, such as ISO 11607 and EUMDR. The position operates within a hybrid work model, with three days in the office and two days working from home. The role involves applying packaging engineering principles to design, prototype, qualify, and improve packaging concepts, as well as identifying and specifying packaging materials and equipment. The engineer will work with moderate guidance and support external resources as needed. This is a mid-level, contract position.
Requirements
- Minimum 3 years of experience in Medical Device packaging
- Bachelor Degree equivalent in Packaging, Mechanical Engineering, Materials Engineering or in a related field of study.
- Demonstrates working knowledge of package engineering principles and techniques
- Demonstrates working knowledge of legal requirements and documents.
- 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.
- US Citizens or GC Holders or GC EAD or OPT or EAD or CPT
Nice To Haves
- Experience with CAD tools for packaging design
- Experience with statistics and design of experiments.
- Knowledge of the following standards: ISO 11607, ISO 13485, ISO 14971
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
- 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, analyses 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.
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
