Risk Management Engineer 3

Intuitive; Mexicali; Presencial; MXN 1,043,000 - 1,392,000; Jornada completa

Descripción de la vacante

A medical technology company in Mexicali is seeking a quality and risk management engineer to join their team. The role focuses on ensuring product reliability, quality, and safety as their robotic surgical systems are adopted by healthcare providers. Ideal candidates will have a background in engineering, experience in risk analysis, and a commitment to quality improvement. This position offers opportunities to make significant contributions to the medical field within a collaborative team environment.

Formación

• Able to navigate quality and compliance system with minimal oversight.
• Understanding of CFR 21 820/ISO 13485 requirements.
• Ability to understand product risks and design controls.

Responsabilidades

• Participate in risk analyses for products.
• Drive quality process improvements.
• Engage with design and quality engineers.

Conocimientos

Risk Management

Quality Advocacy

Data Analysis

Communication Skills

Team Collaboration

Educación

Bachelor's degree in electrical, mechanical or system engineering

Herramientas

Excel

PowerPoint

Agile/ACCS

Descripción del empleo

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Primary Function of Position

As Intuitive’s da Vinci Surgical System and other medical devices become adopted by an increasing population of hospitals, surgeons and patients, we are building a focused team to drive reliability, quality, and safety to ever-better levels. This focus applies to product in use, product in manufacturing, and product in design. Help us powerfully drive our quality mission in our young and growing company by bringing your hands‑on experience in solving tough engineering problems, your fascination with complex electro‑mechanical devices, and your passion for the best practices to design, monitor, and improve product and process. Intuitive seeks a strong technical contributor who can review and process escalation activities, review, and update risk management file documents, and identify key opportunities for product improvement. You will not abide “process red tape”, instead passionately seeking the most efficient way to build in product quality.

Essential Job Duties

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

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

Qualifications

Required Skills and Experience

• 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.

Required Education and Training

• 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.

Working Conditions

• No special physical requirements.
• Onsite. Travel not to exceed 10%.

Preferred Skills and Experience

• Preferred:1 to 3years of working experience in a medical device companyExperience with Agile/ACCS, TrackWise, or other electronic documentation systems (desired)Participation in internal / external audits conductedAware of SPC & Six Sigma methodology and tools ( 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.

Aviso sobre los Controles de Exportación de EE. UU.

De acuerdo con las Regulaciones de Administración de Exportaciones de EE. UU. (15 CFR §, 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.
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 implementación de 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 Plan de Control de Tecnología (“TCP”, por sus siglas en inglés) 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.