Quality Engineer 2

Primary Function of Position

Intuitive seeks a strong technical contributor who can help define practical, useful quality metrics and specifications, identify key opportunities for product improvement, launch quality initiatives, lead projects to implement these initiatives, and serve as an expert consultant to help solve the most technically challenging quality problems.  The ideal candidate possesses a broad base of experience and a high level of technical depth in at least two technical specialties applicable to medical robotics, and is equally at home in the test lab and providing technical leadership to our team as we develop standard practices of our organization.  You will not abide “process red tape”, instead passionately seeking the most efficient way to build in product quality. And you will be also coach, mentor, teach, and influence the engineering staff in best quality practices, data analysis, protocol development, and design for quality and reliability methods.

Essential Job Duties

• Quality Advocacy and Project Management
  • Develop and apply corporate level quality metrics.
  • Lead and project manage quality initiatives in one or more of these focus areas:
    • Product Quality
    • Data Quality
    • Process Quality
• Sustaining/Manufacturing Support
  • Handle projects of various product and subsystem types (electrical, mechanical, optical, etc).
  • Develop measurable goals for quality.
  • Ensuring that the essential performance aspects are mitigated in the product quality plans.
  • Provide guidance to other engineers regarding applicable regulatory and statutory requirements and the applicability of these requirements to the ISI products.
  • Plan and creation quality standards, quality control, and quality assurance procedures, sampling plans, test methods, fixtures, and processes for incoming materials and finished devices.
  • Ensure process compliance through the design and development of comprehensive procedures including work instructions, flowcharts, forms, templates, checklists, and other product or process related documentation, for recording, evaluating, and reporting quality data.
  • Analyze and disposition of discrepant materials.
  • Support manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, inspection method qualification, and defect containments.
  • Support development and execution of process validation and verification test plans, protocols, and reports.
  • Support development and execution of manufacturing line qualification plans, protocols, and reports.
• Failure Analysis
  • Provide quality expertise post market release to the quality engineering support team to analyze the returned product.
  • Perform technical failure analysis based on the physics of failure.
  • Review and interpret complex data analysis rooted in an understanding of our product hardware and software, the physics of failure, and the use conditions in the clinical / operating room environment.
• Any other Quality Engineering related function/responsibility as directed by the manager.

Required Skills and Experience

• Education: Bachelor degree in electrical, mechanical or system engineering, math, or physics. Advanced degree preferred.
• 3+ years of working experience in Quality Engineering, minimum 2 years in medical device design or manufacturing environment.
• English 90%

Required Education and Training

• Able to navigate quality and compliance system with minimal oversight on individual projects.
• Demonstrated understanding of CFR 21 820/ ISO 13485 requirements for making process or design changes.
• Understands product risk management, experience in generate FMEA and process FMEA.
• Understands Design Controls, Change Controls, Product, and Engineering Processes.
• Proficient with generate and execute Qualification and Validation protocol and Quality Assurance Procedures.
• Experienced in leading product containment and rework activities.
• Proficient in SPC & Six Sigma methodology and tools (e.g. uses DMAIC process and basic tools such as 5 Why's, control charts, fishbone diagram).
• Understands typical Excel data analysis operations (e.g. Vlookup, Pivot table and pivot chart functions) Able to create Multi-source report, trends, and interprets data with minimal oversight.
• Capable of thinking independently and make decision based on limited information.
• Capable of initiating improvement discussion and lead the team toward the goal.
• Can present information in various forms and forums, collaborates with peers across functions. Experience in presenting to cross functional mgmt. communications.  (e.g. report writing, presentations, QRB presenter).
• Good creative problem-solving skills.
• Good communication and documentation skills.

Preferred Skills and Experience  

• Understands Design Controls, Change Controls, Product, and Engineering Processes.
• Proficient with generate and execute Qualification and Validation protocol and Quality Assurance Procedures.
• Experienced in leading product containment and rework activities.
• Proficient in SPC & Six Sigma methodology and tools (e.g. uses DMAIC process and basic tools such as 5 Why's, control charts, fishbone diagram).
• Understands typical Excel data analysis operations (e.g. Vlookup, Pivot table and pivot chart functions) Able to create Multi-source report, trends, and interprets data with minimal oversight.

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.