- 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)
- 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).
- 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.
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Risk Management Engineer - Mexicali, México - Intuitive Surgical
Descripción
Company Description
Descripción de la empresaEn 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.
Qualifications
Skill/Job Requirements:
Competency Requirements: In order to adequately perform the responsibilities of this position the individual must possess:
Personality Requirements
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