Project Engineer - Packaging

Descripción

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. Descripción y detalle de las actividades 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 shift 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 Experiencia y requisitos **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 of mindset and behavior is 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 experiencie on Medical device development under FDA Quality Systems Regulations, CE Marking, and/ or ISO Quality Systems with strong hemostasis experience. Beneficios * Seguro de vida * Seguro de gastos médicos * Bonos anuales * Utilidades garantizadas * Servicios medicos en planta * Comedor * fondo de ahorro * Beneficios de acuerdo a la LFT Solicita este puesto directamente a través de nuestro portal SOLICITAR **Número de vacantes** 1 **Área** Ingeniería **Contrato** Permanente **Modalidad** Presencial **Turno** Diurno **Jornada** Tiempo Completo **Horario*** Tiempo completo * Turno Matutino * Lunes a viernes **Estudios** Carrera con título profesional **Inglés** Hablado: Avanzado, Escrito: Avanzado **Disponibilidad p. viajar** No