Job Description Summary
¿Quieres pertenecer a una empresa líder global en tecnología médica que actúa para impulsar el mundo de la salud? Sea parte de algo grandioso!BD es una de las compañías de tecnología médica más grandes del mundo. Tenemos una posición única en el mercado con soluciones para mejorar el manejo de la enfermedad y el manejo de la atención, apoyando a clientes, profesionales de la salud y pacientes en la mejora de la práctica clínica. A nivel mundial, somos más de 65.000 empleados apasionados por lo que hacemos y estamos comprometidos a impulsar el mundo de la salud con soluciones desde el diagnóstico hasta el tratamiento.
Job Description
RESPONSIBILITIES
Process Development (Quality, Efficiency and Harmonization):
- Responsible for the design of molds/presses, responsible for user requirements specifications (URS) to ensure it meets specific manufacturing requirements.
- Provide cost input (equipment, engineering, materials) into CB-2.
- Manage the integration of new equipment through SAT completion, and support Equipment Integration during install and startup. Implement Process Design on new equipment and ensure product designs are being met.
- Provide feedback and validate that the equipment design meets safety and operational standards based on experience and validation from respective stakeholders.
- Leads suppliers and external design teams (vendor) for larger capital projects to manage cost, lead time and scope.
- Partnerships with procurement for vendor selection.
- Active participant with suppliers regarding process optimizations and continuous improvements on molding projects
- Captures process performance from sites, existing molds.
- Responsible for vendor contracts in collaboration with procurement and legal.
- Develop innovative concepts for mechanical systems and equipment based on project requirements, industry trends, and standard methodologies.
- Create, or obtain from the vendor, detailed 3D models/2D drawings of mechanical components and assemblies using CAD software.
- Create and maintain design documentation, including user requirement specifications, assembly instructions, bill of process, etc.
- Optimize equipment designs to minimize production costs and changeover time, simplify assembly processes, design from the operator’s standpoint,maintainability, and ensure manufacturability.
- Participate in design reviews, risk assessments, and continue to build failure mode and effects analysis (FMEA) to ensure reliability, safety, performance of mechanical systems/equipment.
- Collaborates with manufacturing teams to build and test prototypes of mechanical systems and components, gathering feedback, iterating on design as necessary.
- Perform various engineering analyses / simulation (i.e. stress, strain, thermal, fluid dynamics) to validate and optimize design.
- Work closely with other engineering fields. (i.e. electrical/mechanical engineers) to ensure seamless integration of mechanical systems with other project components.
- Support operations during a production crisis. (quality, supplier, etc.)
- Comply with all local, state, federal, and BD safety regulations, policies, and procedures.
- Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.
- Other duties as assigned.
EXPERIENCE/EDUCATION
Minimum Education:
- Bachelor’s Degree in Mechanical Engineering, Controls Engineering or related field, or relevant equivalent experience.
Minimum Experience:
- Tooling design experience is desired
- Proficiency in SolidWorks or other 3d modeling software is desired
- Excellent technical skills including project management, organization, planning, and capital budgets relating to mold procurement and verification.
- Demonstrated ability to apply problem solving and data analysis methods.
- Previous experience with Good Manufacturing Practice (GMP), ISO standards and Lean Manufacturing concepts desired.
- Experience in an FDA regulated quality environment desired.
- Willingness and ability to travel domestically and internationally up to 25%.
- Experience leading projects end to end.
- Strong communication skills
- Risk analysis / FMEA
- Statistical analysis / SPC system
- Ability to manage multiple conflicting priorities, and to develop and maintain tool qualification schedules.
Required Skills
Optional Skills
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Primary Work Location
MEX Nogales North - Luis Donaldo Colosio BlvdAdditional Locations
Work Shift
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"Purpose driven company where associates work every day to make healthcare better. A lot of great initiatives going on to make BD the best MedTech company in the world."
Anonymous, Franklin Lakes, NJ