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Lead Packaging Engineer

2 months ago

Indiana, Pennsylvania, United States Intuitive Full time

Position Overview:

The selected candidate will be an integral part of the Packaging Engineering team, focusing on the design and validation of packaging systems for various medical instruments, accessories, endoscopes, and system Field Replaceable Units (FRUs) across all business sectors of Intuitive.

This role includes mentoring and guiding junior team members in their technical development.

The responsibilities encompass the design, validation, and verification of diverse packaging systems, which include—but are not limited to—thermoform packaging such as Form, Fill & Seal trays, rigid trays, pouch sterile barrier systems, custom cartons, shippers, over shippers, and reusable cases. Additionally, the role involves selecting suitable label stock for all products.


Key Responsibilities:


1. Develop innovative packaging solutions for both sterile and non-sterile medical devices, including Field Replaceable Units (FRUs), from initial concept through to commercialization.

2. Address packaging requirements from concept to end-of-life.
3. Create packaging solutions that fulfill both internal and external customer specifications.
4. Oversee all aspects of design verification for packaging systems to ensure compliance with design requirements and readiness for production.
5. Collaborate with manufacturing and process engineering teams to implement packaging designs suitable for a class 8 clean-room environment.
6. Identify and introduce new packaging processes aimed at enhancing efficiency and reducing costs.
7. Develop component specifications, inspection plans, and packaging protocols/reports to ensure that packaging systems meet performance criteria.
8. Manage change requests within the document control framework.
9. Support the qualification of sealing and packaging processes within clean room settings.

10. Ensure that all projects adhere to internal and external packaging compliance standards, preventing any impact on product launch timelines.

11. Establish organizational standards for packaging requirements related to Intuitive products.
12. Act as a Subject Matter Expert (SME) for packaging, providing support during audits, addressing non-conformances, and managing Corrective and Preventive Actions (CAPAs) as necessary.

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