Project Engineer - Packaging

Description

Summary: A Packaging Engineer designs, develops, and tests packaging systems to protect products, minimize costs, ensure sustainability, and maintain sterile barriers for medical devices. Highlights: 1. Design and develop packaging systems for product protection and cost efficiency. 2. Critical role in patient safety and regulatory compliance for medical devices. 3. Involves sterile barrier system design and performance testing. Job Description and Detailed Activities A Packaging Engineer is responsible for the design, development, and testing of packaging systems to protect products, minimize costs, and ensure sustainability. They bridge the gap between R\&D and technical engineering to ensure a product moves safely and efficiently from the manufacturer to the final consumer. The role for a Packaging Engineer shifts from general logistics to a critical function of patient safety and regulatory compliance. Their primary objective is to develop packaging that maintains a sterile barrier and ensures a device remains functional until the moment of use. **Core Responsibilities** Design \& Prototyping: Creating structural packaging designs using CAD software (e.g., SolidWorks, AutoCAD) for primary, secondary, and tertiary layers. TOPS software is desired. Sterile Barrier System (SBS) Design: Designing primary packaging (e.g., pouches, trays) that allows for terminal sterilization (Ethylene Oxide, Gamma, E\-Beam, etc.) while preventing microbial ingress. Material Selection: Evaluating and selecting materials—such as plastics, paperboard, glass, or metals—based on product requirements, cost, and environmental impact. Performance Testing: Developing and executing test protocols (e.g., ISTA, ASTM) to validate packaging durability against hazards like vibration, shock, moisture, and temperature fluctuations. Regulatory Documentation: Authoring highly technical protocols and reports for FDA or EU MDR submissions, including Design History Files (DHF) and Technical Files. Validation \& Verification (V\&V): Executing rigorous testing to meet ISO 11607 standards, including Seal Integrity Testing: Bubble emission, dye penetration, or burst testing https://haemonetics.wd5\.myworkdayjobs.com/HAE/job/Tijuana\-Mexico/Project\-Engineer\-Packaging\_R10447 Experience and Requirements **Skills:** * Requires strong technical skills together with excellent interpersonal and administrative skills. * Knowledge of modern product development and project engineering principles, methods and practices. * Experience working as part of a cross\-functional product development team is critical. * Continuous improvement mindset and behavior are desirable. * Working knowledge of related disciplines such as assay development, manufacturing processes, planning, budgeting and resource planning. **Education:** BS in Packaging Engineering, Industrial Engineering or a relevant Engineering discipline with a concentration in Manufacturing. **Experience**: Minimum 3\-5 years experience in Medical device development under FDA Quality Systems Regulations, CE Marking, and/ or ISO Quality Systems with strong hemostasis experience. Benefits * Life insurance * Medical expense insurance * Annual bonuses * Guaranteed profit sharing * On-site medical services * Cafeteria * Savings fund * Benefits according to the Federal Labor Law (LFT) Apply for this position directly through our portal APPLY **Number of openings** 1 **Department** Engineering **Employment type** Permanent **Work mode** On-site **Shift** Day shift **Working hours** Full-time **Schedule*** Full-time * Morning shift * Monday to Friday **Education** Bachelor's degree **English** Spoken: Advanced, Written: Advanced **Willingness to travel** No