Risk Management Engineer 3

Primary Function of Position

As Intuitives 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 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 :

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 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 Whys control charts fishbone diagram).
• Personality Requirements

• Able to cope with changes and uncertainties; and handle associated risks comfortably.
• Ask questions and dont 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. Doesnt 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 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.

Remote Work :

No

Employment Type :

Full-time