As a Senior Packaging Engineer, you will play a key role in the design and development of packaging solutions for our disposable medical devices and capital equipment.
You will be a key contributor / leader on cross-functional teams, tasked with providing technical guidance, and ensuring our products meet customer and regulatory requirements.
This role is expected to provide technical and functional leadership / supervision as required as the organization grows.
Scroll down for a complete overview of what this job will require Are you the right candidate for this opportunity
Primary Duties and Responsibilities :
- Design, develop and maintain sterile packaging systems for disposable medical devices and capital equipment. (Corrugate, films, Tyvek, sterile pouches / trays, coiling / catheter restraint systems, clips / tape / mfg. packaging fixtures)
- Design, develop and maintain non-sterile packaging systems for medical device hardware. (Corrugate, foam, trays, pallets, etc.)
- Ensure packaging meets sterilization requirements and maintains product integrity.
- Conduct material selection and testing for packaging components
- Generate protocols, test reports, and engineering adoptions and maintenance of test documentation per approved documentation system per quality standards
- Create Bill of Materials and generate Engineering Change Orders in support of new products and various revisions or maintenance.
- Provide supporting packaging documentation to Regulatory and Quality for submissions and audits.
- Optimize packaging for cost-effectiveness and sustainability
- Support product design changes to develop and improve existing products that affect existing packaging
- Support packaging labeling changes
- Collaborate with cross-functional teams (R&D, Manufacturing, Quality, Regulatory)
- Manage packaging validation processes and documentation.
- Effective collaboration with outside testing services and test labs.
- Ensure correct processes, work instructions, test methods within PDP and Design Control.
- Stay current with industry regulations and packaging technologies (ISTA, ASTM, ISO, etc).
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