Responsibilities :
- This Packaging Engineer (Consultant) will provide guidance, ownership, and execution of all packaging design, sterilization validation, and sustainability efforts for multiple Class III medical devices.
- This person will not be running the actual test- the tests will be done at an external lab.
- The consultant will use the client's template to write the protocol.
- This will go out to the lab for testing, when it comes back, the consultant will write the documentation.
Requirements :
- Design and validation testing of intercompany shipment containers for all products including the client's heart pump and all associated accessories.
- Define and execute real-time and accelerated aging testing to ensure sterile barrier durability.
- Assess human factors and design + validate commercial device packaging to maximize customer satisfaction.
- Coordinate with suppliers to develop packaging and shipping methods which ensure raw component quality and durability.
- Coordinate with the sterilization facility to ensure routine revalidation and device testing is aligned with industry and regulatory requirements.
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