Descripción y detalle de las actividades
Plans and leads process development activities including design, prototyping, testing (verification and validation) risk management/process FMEA, process characterization, and documentation. Participate in the redesign of existing processes to improve quality, utilize automated production techniques, optimize process capabilities, and product improvements in a more cost-effective manner.
Provide technical expertise in developing new assembly tooling, guidance in processing and troubleshooting.
Interface with new product development and manufacturing to understand product requirements and establish design criteria for manufacturing processes.
Interact with suppliers to define and evaluate materials and processes needed for effective execution of process development activities.
Responsible for validations, IQ/OQ/PQ, product production within agreed upon scope, budget, timeline, and quality.
Interact with suppliers to debug problems with production parts, processes and equipment.
Interface with procurement to obtain quotations, purchase components.
Advise other engineering personnel on technical aspects of product/process design, assembly techniques and the validation of processes.
Interface with engineers, manufacturing, and lab technicians to design and develop new fixtures and tooling.
Support product related technical problems in engineering and manufacturing areas.
Develop comprehensive manufacturing strategy for all projects that will include alternate methods for component acquisition including timelines, costs, capital, expense, risk, and recommendations
Interface with suppliers and manufacturing when implementing new processes.
Coordinate with SBU planning for initial and ongoing supply, safety stock, distribution management including shelf life, and alternate suppliers for critical components
In conjunction with Quality establish AQL levels for each component and incoming inspection criteria including location, method of measurement, consistent data recording, disposition.
Experiencia y requisitos
Bachelor level degree in engineering
3+ years previous experience in related field (e.g., medical device manufacturing and assembly, disposables manufacturing processes, plastics, automation).
Strong bilingual (English/Spanish) communication and presentation skills (written and verbal).
Ability to work effectively with other product development team members.
Experience in the medical industry / Knowledge of ISO 13485.
*** The site to work is in Tecate Site.
Beneficios
Beneficios de acuerdo a la LFT
Fondo de ahorro
Transporte
Utilidades garantizadas
Servicios medicos en planta
Comedor
caja de ahorro
comedor
fondo de ahorro
servicios médicos en planta
