Job description :

Looking for Packaging Engineer.

Responsibilities :

- Apply working knowledge, under general guidance, on concepts, principles, and technical capabilities for projects of moderate scope and complexity.

- Lead and support cross-functional projects, across global time zones, for new product commercialization and changes to existing products.

- Establish and manage packaging project schedules.

- Develop and validate sterile and non-sterile packaging and labeling systems.

- Qualify new packaging materials, equipment, and suppliers.

- Ensure compliance with and monitor changes to packaging regulations.

- Identify, lead, and support cost savings initiatives.

- Write and coordinate technical documentation, including protocols, reports, procedures, specifications, work instructions, and original data.

- Develop and validate test methods and associated procedures

- Mentor new hires within department.

- Communicate regularly with Global Packaging & Labeling.

Essential Functions of the Role : Conduct packaging validations in a manufacturing environment.

Work Experience Requirements :

- Medical device packaging system development and validation

- Sterile barrier forming and sealing process validation

- Design of experiment and statistics

- Statistical analysis

- Test methods for materials, integrity, physical properties, distribution simulation, and aging

- Packaging material and supplier selection

- Rigid and flexible sterile barriers

- Fiber-based materials, including paperboard and corrugate

- Porous and non-porous packaging materials

- Sterile barrier form-fill-seal and heat seal equipment

- Manual and automated packaging processes

- Labeling substrates

- Labeling printers and systems

- Labeling equipment and vision systems

- Sterilization processes

- Technical writing

- Optimization and cost savings

Specialized Skills/Technical Knowledge :

- Familiar with ISO 11607, EU MDR, UDI, GS1, ASTM D10 and F02, ISTA

- Familiar with BIOVIA MyQumas, DocCompliance, and ProcessCompliance, SAP, CAPE, TOPS, Minitab, Microscan or similar systems

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