Packaging and Labelling Engineer

About the role

Design and develop primary, secondary, and tertiary packaging for wound care products. This role involves selecting packaging materials in consideration of product protection, sterility, barrier properties, shelf life, transportation and sustainability, and leading packaging projects related to new product development launches.

Key responsibilities

• Design and develop primary, secondary, and tertiary packaging for wound care products
• Select packaging materials in consideration of product protection, sterility, barrier properties, shelf life, transportation and sustainability
• Fulfill MDR and FDA requirements regarding Performance Testing of Shipping Containers and Systems in Compliance to ASTM D4169 or ISTA (510k registration) as required
• Review and oversee packaging validations in compliance to ISO 11607 (Packaging for terminally sterilized Medical Device)
• Lead packaging projects related to new product development launches by developing packaging design and equipment/machine that provides products protection and stability
• Lead troubleshooting in the resolution of packaging related issues in manufacturing and in the field
• Provide support to manufacturing issues related to packaging, labelling, IFU's, CAPA's, NC's, audits and SCAR
• Interface with external labs (local or overseas) to initiate packaging related testing plans
• Create, review and update packaging related to SOP's, drawings, BOM's, technical documentation or Work Instruction (WI)
• Develop and maintain labels, IFU's, carton, artwork and ensure compliance with EU MDR, FDA, UDI, GS1, and HIBC-128 requirements

About you

• Bachelor's degree in a related engineering/science field; graduate or advanced degree strongly preferred
• Experience in packaging, labelling or IFU
• Familiarity with Unique Device Identification (UDI) requirements and global barcode standards such as GS1 and HIBC-128
• Proficient in BarTender, CANEA, Adobe Creative Suite (Illustrator, Indesign, Acrobat)
• Proficient in Packaging design software like TOPS Pro or ArtiosCAD
• Dynamic team player and leader that can work effectively and proactively collaborate on cross-functional teams
• Experience in Medical device product development including innovation and project/program management, design concept, risk analysis, problem solving skills and technical leadership
• Strong communication and presentation skills to lead or facilitate effective discussions and relay technical and/or project information to key stakeholders
• Familiarity with ISO 13485, MDR, FDA 21 CFR Part 820 Design Control, ISO 14971, GMP and other standards as they relate to the development and manufacture of medical devices
• Strong organizational and time management skills to meet deadlines while managing multiple projects