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Risk Management Engineer

Company Description

Descripción 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

This position has responsibility and authority for:

90% Risk Management document support, 10% quality advocacy and project management.

  • Risk Management
    • Participate in Risk Analyses for new and existing products, including review of both hardware and software.
    • Using data from Post Market reviews, update risk documentation as needed, following confirmations with Project QEs and Design Engineering.
    • Work with Design Engineering to maintain tracing of risk to requirement to test.
    • Work with Manufacturing Engineering on process risk documents
    • Participate in review of technical and quality information for regulatory submissions.
  • Quality Process Improvements
    • As needed, participate in Quality process improvement projects (CAPA, Process NonConformance, Quality Plans, other process improvements)

Qualifications

Skill/Job Requirements:

Competency Requirements: In order to adequately perform the responsibilities of this position the individual must possess:

  • English Level:  High (Good writing and speaking skills in English)
  • Education: Bachelor degree in electrical, mechanical or system engineering, life sciences, mathematics, or physics. Advanced degree is a bonus.
  • Able to navigate quality and compliance system with minimal oversight on individual projects.
  • Basic knowledge of CFR 21 820/ ISO 13485 requirements for making process or design changes.
  • Understands product risks, able to work with design and quality engineers to update risk documents.
  • Understands Design Controls, Change Controls, Product, and Engineering Processes.
  • Uses data to quantitatively communicate problem or issue.
  • Basic functionality in PowerPoint
  • Understands typical Excel data analysis operations (bonus for Vlookup, Pivot table and pivot chart functions).
  • Works with Peers to understand and document issues.
  • Operates with minimal oversight for basic problems or assignments, and escalates appropriately for issues requiring clarification.
  • Preferred:
    • 1 to 3years of working experience in a medical device company
    • Experience with Agile/ACCS, TrackWise, or other electronic documentation systems (desired)
    • Participation in internal / external audits conducted
    • Aware of SPC & Six Sigma methodology and tools (e.g. uses DMAIC process and basic tools such as 5 Why's, control charts, fishbone diagram).

Personality Requirements

  • Able to cope with changes and uncertainties; and handle associated risks comfortably.
  • Ask questions and don’t stop at the first answer. Analyze deeply to ensure the solution is the most effective solution.
  • Brings unpleasant facts to discussion, does not hold back information.
  • Driven by results. Fully supports team decision, even if he/she disagrees with the decision.
  • Enjoys working hard and learning when opportunities arise.
  • Gives credit to others for success, and does not blame others for his/her mistakes. Doesn’t misrepresent him/herself for personal gain or protection.
  • Listens and respects others. Demonstrates constructive work relationship with others in the organization.
  • Offers suggestions for doing things differently, brings measurable evidence to support each decision. Able to breakdown complex issues into simplified task.
  • Sets priority and manages time wisely, capable of identifying the critical issues from the trivial issues. Sets individual goals aligning with the team goal.
  • Understands that the real success is the success of the whole team.

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: 10% of the time

The Future is Intuitive

At Intuitive, we envision a future where care is more connected, customized, and intelligent—so the question won’t just be how long we live, but how well.

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Like the patients we serve, your health is also very important to us.

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