Functions and Responsibilities Lead the development of User Requirements Specifications (URS) for assembly and packaging equipment, covering mechanical, electrical, and process requirements to support safe, compliant, and manufacturable solutions. Support capital project development by capturing site process performance data and contributing to capital appropriation documents and business cases. Manage the integration of new equipment through FAT, SAT, installation, startup, and handover, ensuring process designs are correctly implemented and product requirements are met. Review and validate equipment designs to confirm compliance with safety, operational, and quality standards, incorporating feedback from cross‑functional stakeholders. Coordinate with suppliers and external design teams for assigned capital projects, supporting scope, schedule, and cost objectives in collaboration with Procurement. Partner with Procurement and Legal to support vendor selection, technical input to contracts, and supplier execution for tooling and equipment. Support the development of innovative mechanical and equipment concepts, applying standard methodologies and industry best practices to meet project requirements. Create, review, or obtain 2D/3D CAD models and drawings for mechanical components and assemblies, ensuring alignment with design intent and manufacturability. Develop and maintain design and process documentation, assembly instructions, bills of process, and related technical files. Optimize equipment and tooling designs to improve cost, changeover efficiency, ergonomics, maintainability, and manufacturability, with an operator‑focused perspective. Participate in equipment design reviews, risk assessments, and FMEA activities, supporting reliable, safe, and high‑performing equipment solutions. Collaborate with Manufacturing, Maintenance, and other engineering disciplines to build, test, and refine prototypes and support seamless system integration. Perform or support engineering analyses and simulations (e.g., stress, thermal, fluid flow) as needed to validate and optimize designs. Ensure compliance with BD quality systems, safety requirements, and applicable regulatory standards, consistently applying sound quality and engineering practices. Requirements Bachelor of Science degree in Engineering (Mechanical, Electrical, Chemical, Manufacturing, or related discipline) required. Minimum of 5+ years of engineering experience, with preference for experience supporting automated manufacturing equipment and process development in high‑volume production environments. Experience within medical device, in‑vitro diagnostics, or pharmaceutical manufacturing environments is highly desirable. Demonstrated experience implementing process improvements and launching new equipment into manufacturing, including participation across all major phases of capital projects such as concept development, scoping, budgeting, URS/specification development, supplier quoting, capital proposals, vendor coordination, installation, qualification, validation, and production ramp‑up. Proven ability to work on cross‑functional engineering initiatives, supporting integration of equipment, tooling, automation, and processes to meet safety, quality, cost, and performance requirements. Experience with label printing systems and barcode specifications, including regulatory considerations and integration into automated manufacturing or packaging lines. Familiarity with packaging and labeling cost analysis to support equipment selection, process decisions, and business case development. Strong technical proficiency in manufacturing equipment and tooling systems, including mechanical design and integration with PLC‑based automation and controls. Proficient in CAD tools (AutoCAD, SolidWorks or equivalent), with ability to create, review, and modify equipment, tooling, and layout designs in collaboration with suppliers and internal teams. Solid project execution skills, including planning, organization, scheduling, and tracking of capital projects related to tooling, molds, automation, and equipment verification. Demonstrated ability to apply structured problem‑solving techniques and data analysis, including root cause analysis and basic statistical methods, to address equipment, process, and quality issues. Hands‑on experience applying risk management tools, including FMEA, to identify and mitigate technical and operational risks during equipment design, integration, and validation. Working knowledge of GMP, ISO standards, FDA‑regulated quality systems, and Lean Manufacturing concepts, with experience applying these requirements within manufacturing and equipment projects. Proven experience supporting new product and equipment launches, including FAT, SAT, installation, qualification and production ramp‑up at BD manufacturing sites, alternate BD locations, and/or external suppliers. Location Primary Work Location: MEX Reynosa. Equal Opportunity Employer Statement Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics. #J-18808-Ljbffr
Gie Edi Senior Engineer
BECTON DICKINSON
reynosa, reynosa
Publicado hace 7 días
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