Descripción del empleo
Primary Function of Position.
Contribute your leadership and technical skills in the areas of manufacturing process technologies, problem-solving, training, and project management in a growing medical device company. In this key role, you will be the driving force behind Lean tool implementation and continuous improvement projects site wide. Your combination of training, motivational skills, analytical problem-solving ability, and passion for Lean manufacturing will be just the right fit for the manufacturing environment of precision instruments for minimally invasive robotic surgery.
Essential Job Duties.
- Manufacturing responsibility for tooling/fixtures, manufacturing equipment, and design improvements in production.
- Evaluate and challenge mechanism designs for reliability, functionality, and manufacturability. Provide suggested change proposals.
- Approve design releases to manufacturing, review engineering documentation, and provide vendor and in-house DFM inputs.
- Review/approve and determine the impact of ECOs from manufacturing and field perspectives.
- Take responsibility for developing and maintaining compliance with the quality system.
- Evaluate and help in the selection of suppliers for mechanical parts if required. Help resolve supplier quality issues.
- Update and revise Manufacturing Process Instructions (MPIs) to ensure accuracy and completeness.
- Address line support issues as they arise.
- Document and report any variances, problems, issues, or concerns on all aspects of the manufacturing process.
- Provide production personnel with expectations and performance feedback regularly in the production process.
- Drive improvements in safety, quality, production, and cost.
- Understand, train personnel, and enforce strict adherence to the applicable Department Operating Procedures (DOPs) and Standard Operating Procedures (SOPs) of the Quality System.
- Maintain up-to-date and accessible training records for MPIs and Quality System documents.
- Assist in setting and attaining quarterly and annual production goals.
- Learn and enforce company safety policies and practices.
- Review and disposition of discrepant material in the manufacturing line.
- Implement corrective actions to prevent recurrences.
- Active participant in quality improvement initiatives, providing feedback to find the root cause and problem-solving.
- Design and documentation responsibilities for custom and standard production tooling/fixtures.
- Process and part design/documentation duties for cost reduction programs.
- Execute and present Equipment Qualification Reports
- Define Preventive Maintenance, calibration and troubleshooting procedures.
- Define Startup Instructions of Equipment
- Provide feedback for operation of equipment for Manufacturing Process Instructions
- Transfer new manufacturing lines or equipment, interface with logistics for movement of equipment.
- Participate in continuous improvement projects related to manufacturing equipment.
- Perform Hardware and Software updates of equipment.
- Generate and Submit ECOs
- Modify and improve Fixtures.
- Interface with external vendors for service, calibration or purchasing of equipment.
Requisitos
Required Skills and Experience
- Must be able to speak, read and write in English 90%.
- Must be able to travel to the USA.
- Strong communications skills across team organizations and cultures.
- Statistical analysis – Utilizes Statistical techniques to identify patterns and analyze trends.
- Familiarity with Root Cause Analysis and FMEA.
- Experience with CAD Software.
- Full understanding of Engineering/Technical Drawings and Product Specifications.
- Experience supporting Process Improvement initiatives and/or new process/product introduction.
Required Education and Training
- Bachelor of Engineering in Mechanical Engineering, Mechatronics Engineering, Biomedical Engineering, Electronic Engineering or Related discipline.
Preferred Skills and Experience
- Mexico – US Customs and supply chain knowledge.
- Mid/high volume complex mechanism manufacturing engineering experience.
- Experienced in FDA Quality System Regulation, ISO 13485 and/or medical device manufacturing environment.
- Strong organizational and time management.
- Demonstrated experience with Process Development, Equipment Validation and Mfg. Scale-up.
- Ability to conduct/lead projects in process improvement, capacity increase, and cost reduction.
Información adicional
Intuitive es un empleador que brinda igualdad de oportunidades de empleo. Proporcionamos igualdad de oportunidades de empleo a todos los solicitantes y empleados cualificados, y prohibimos cualquier tipo de discriminación y acoso, independientemente de su raza, sexo, condición de embarazo, orientación sexual, identidad de género, origen nacional, color, edad, religión, condición de veterano protegido o de discapacidad, información genética o cualquier otra condición protegida por las leyes federales, estatales o locales aplicables.
Aviso sobre los Controles de Exportación de EE. UU.: De acuerdo con las Regulaciones de Administración de Exportaciones de EE. UU. (15 CFR §743.13(b)), algunos puestos en Intuitive Surgical pueden estar sujetos a controles de exportación de EE. UU. para candidatos que sean nacionales de países actualmente bajo embargo o sanciones.
Cierta información que usted proporcione como parte de la solicitud será utilizada para determinar si Intuitive Surgical necesitará (i) obtener una licencia de exportación del gobierno de EE. UU. en su nombre (nota: el proceso de obtención de la licencia puede tardar entre 3 y más de 6 meses) o (ii) implementar un Plan de Control de Tecnología (“TCP”, por sus siglas en inglés) (nota: normalmente este paso agrega 2 semanas al proceso de contratación).
Para cualquier puesto en Intuitive sujeto a controles de exportación, las ofertas finales están condicionadas a la obtención de una licencia de exportación aprobada y/o a la ejecución de un TCP antes de la fecha de inicio del empleado potencial, la cual puede o no ser flexible, y dentro de un plazo que no obstaculice de manera irrazonable la necesidad de contratación. Si aplica, los candidatos serán notificados e instruidos sobre cualquier requisito relacionado con estos fines.
Este puesto puede cubrirse con un nivel de puesto diferente al indicado aquí, según las necesidades del negocio y/o la experiencia, los conocimientos y las habilidades del candidato o la candidata seleccionado. La compensación se basará principalmente en el nivel del puesto en el que se cubra el rol y en las cualificaciones del candidato o la candidata, de conformidad con la legislación aplicable.
Descripción de la empresa
It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.
We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.
The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.
If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.
