Manufacturing Engineering Mgmt 3

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.

We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.

If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.

Primary Function of Position:

To define and execute the strategy for the Manufacturing Engineering area that will promote the continuous improvement and support to released production processes for Instruments and Accessories to ensure reliability, cost, manufacturability and serviceability.

To manage and coordinate the resources and activities of the Manufacturing Engineer area and provide mechanical and manufacturing support in accordance with FDA 21 CFR820 and ISO 13485 standard regulations. Define budget of the department and execute as planned. This position requires minimal to no supervision.

Roles & Responsibilities:

• Lead initiatives focused on yield improvement, material cost reduction, capacity enhancement, and outsourcing of assemblies.

• Evaluate and challenge mechanism designs for process reliability, serviceability and manufacturability. Provide suggested change proposals.

• Creating budget estimates for tooling, test equipment, prototype designs, and first article activities.

• Ensure the processes meet the specified requirements for operation including adherence to parameters, specifications avoiding variations in the manufacturing process.

• Coach and lead a team of engineers and/or equipment technicians.

• Provides technical support analyzing and /or performing failure analysis for discrepant production components, assemblies and field returns.

• Qualify, document and introduce production processes.

• Take responsibility for developing and maintaining compliance with the quality system.

• Evaluate and select suppliers for mechanical parts. Help resolve supplier quality issues.

• Must possess strong communication skills to interface with suppliers, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing organizations.

• Performs other duties as required.

• Travel: Position may require 5-10% travel, primarily within U.S.

• Drive our Culture Strategy by fostering our mission, founding principles, individual and leadership expectations.

Skills, Experience, Education, & Training:

Required:

• Candidate must be of high character and energy with regard for detail.

• Demonstrated Mechanical and/or Process Engineering ability.

• Demonstrated ability in failure analysis and continuous improvement.

• BS degree in Mechanical Engineering or equivalent.

• Minimum 3 years manufacturing engineering supervision experience with Mid/high volume complex manufacturing processes.

Preferred:

• MS degree in an Engineering discipline.

• 3 to 5 years of experience as a Manager at manufacturing engineer supporting product with significant mechanical/process content.

• Prior experience with various mechanical and or electronics applications and technologies, including reliability and performance assessment.

• Prior experience working in FDA 21 CFR820/ISO 13485 medical device manufacturing environment.

• Demonstrate ability to design/execute experiments.

• Prior responsibility for process or product validation/verification.

• Experience with ASME Y14.5 Geometric Dimensioning and Tolerance.

• Experience in Just-In-Time, Demand Flow Technology, and Lean Manufacturing techniques

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.