Senior Cleanroom Engineer

hace 1 mes

Mexicali, México Intuitive Surgical A tiempo completo
Company DescriptionDescripción de la empresa

En Intuitive, estamos unidos detrás de nuestra misión: creemos que la atención mínimamente invasiva es la atención que mejora la vida. Mediante la inventiva y la tecnología inteligente, ampliamos el potencial de los médicos para curar sin limitaciones.

Como pioneros y líderes del mercado en cirugía robótica, nos esforzamos por fomentar un equipo inclusivo y diverso, comprometido con marcar la diferencia. Durante más de 25 años, hemos trabajado con hospitales y equipos de atención de todo el mundo para ayudar a resolver algunos de los desafíos más difíciles de la atención médica y avanzar en lo que es posible.

Intuitive se ha construido gracias a los esfuerzos de grandes personas de diversos orígenes. Creemos que las grandes ideas pueden provenir de cualquier lugar: nos esforzamos por fomentar una cultura inclusiva basada en la diversidad de pensamientos y en el respeto mutuo. Lideramos con inclusión y capacitamos a los miembros de nuestro equipo para que trabajen de la mejor manera y manifiesten su auténtica personalidad.

Las personas apasionadas que quieren marcar la diferencia impulsan nuestra cultura: los miembros de nuestro equipo se basan en la integridad, tienen una sólida capacidad para aprender, la energía para hacer las cosas, y aportan experiencias diversas del mundo real para ayudarnos a pensar de nuevas maneras. Invertimos activamente en los miembros de nuestro equipo para apoyar su crecimiento a largo plazo y así poder continuar avanzando en nuestra misión y alcanzar su máximo potencial.

Únase a un equipo comprometido a dar grandes pasos hacia delante para una comunidad global de profesionales de atención médica y sus pacientes. Juntos, avancemos en el mundo de la atención mínimamente invasiva.Job Description

The senior cleanroom engineer is the ISI subject matter expert for Controlled Environment Room (CER) regulatory standards and compliance, operational procedures, and industry best practices.  Manage and continuously improve CER operating procedures and controls and drive implementation across the organization. 

Roles & Responsibilities:

  • Specify and participate in new CER designs, startup, and validations
  • Develop CER specifications and operating procedures as needed for new product, process, or regulatory requirements.
  • Review, manage, and approve changes or modifications to CERs, new processes, equipment, and materials.
  • Develop, promote, and implement CER operations training programs and initiatives
  • Train, coach, and advise colleagues and new hires as needed for problem solving, risk management, and CER best practices
  • Specify, review, and approve consumable operating and cleaning supplies
  • Challenge, continuously improve, and document CER cleaning methods, frequency, and efficacy
  • Document requirements and assist in evaluating new CER service suppliers for capability, infrastructure, and compliance. Ensure CER service suppliers are trained to relevant ISI procedures
  • Drive consistent practices across all sites, domestic and international
  • Drive, manage and review environmental and product nonconformance issues
  • Subject matter expert for cleanroom operations during quality and regulatory audits, such as FDA, MDSAP, and other governments and agencies

 

Qualifications

Skills, Experience, Education, & Training:

  • 5 -10years relevant experience in a medical device or pharmaceutical company.
  • Bachelor’s degree in Engineering, Microbiology, Quality, or similar
  • Bilingual English and Spanish, capable of fluent business conversations (English 80% and over)
  • Demonstrated understanding of medical device QMS and regulatory requirements, including but not limited to FDA CFR 21 820, ISO13485, ISO14644, ISO14698, IEST RPs.
  • Demonstrated understanding of engineering change controls, process verification and validation, and production and process controls in a medical device Controlled Environmental Room
  • Experience with developing and maintaining Standard Operating Procedures and Work Instructions
  • Experience with the planning, construction, startup, troubleshoot and validation of new Controlled Environmental Rooms and facilities.
  • Participation in internal /external quality and regulatory compliance audits
Additional Information

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.

Shift: Day
Travel: 25% of the time

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