Packaging Engineer - Medical Devices Services (2-6 yrs)
Job description :
Looking for Packaging Engineer.
- 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