Sr. Packaging Engineer

Our mid-sized medical device client is adding a Senior Packaging Engineer. In this role, 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.
Your role with the company:

• 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).

• Bachelor's degree in Packaging Engineering, Materials Science, Mechanical Engineering, Manufacturing Engineering, or related field
• 3+ years of experience in medical device packaging
• 5+ years of experience in medical device industry
• Knowledge of sterilization processes and their impact on packaging
• Familiarity with FDA, ISO, and other relevant regulatory standards
• Basic Knowledge of ISO 11607, ISTA, and ASTM Test standards associated with Medical Device Packaging
• Experience with Tyvek, corrugate, films, HIPS trays and other medical-grade packaging materials
• Strong analytical and problem-solving skills (root cause analysis techniques)
• Excellent communication and teamwork abilities
• Proven project management skills
• Experience with coordinating services to outside testing vendors
• Self-starter with strong initiative and personal accountability

• Experienced in the design of experiments, data analysis, statistical methods and presentation of results
• Proven history or packaging design changes improving reliability and/or COGS