Manufacturing Engineering Manager

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.
• 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.

Required

• Manufacturing Engineering Manager background required
• Minimum 3 years of direct people management experience within Manufacturing Engineering, including performance management, coaching, employee development and prioritization of engineering resources.
• Strong experience supporting sustaining manufacturing in a mid/high-volume complex manufacturing environment.
• Strong NPI processes and project execution experience.
• Strong product/line transfer experience is mandatory.
• Demonstrated ability to lead cross-functional teams across Manufacturing Engineering, Operations, Quality, NPI and other supporting functions.
• Demonstrated Mechanical and/or Process Engineering technical capability.
• Strong experience in root cause analysis, corrective actions, process improvement and problem solving.
• Experience with process/equipment validation and qualification (IQ/OQ/PQ/PPQ).
• Demonstrated ownership of manufacturing KPIs such as Yield, Quality, Throughput, Capacity, Scrap/Cost and Equipment Performance.
• Demonstrated ability to prioritize multiple competing business needs, drive accountability and deliver results through a team.
• Strong communication and escalation skills with the ability to influence across functions and organizational levels.
• BS degree in Mechanical Engineering or equivalent engineering discipline.
• Medical Device manufacturing experience strongly preferred.

Preferred:

• MS degree in an Engineering discipline.
• 7-8+ years of Manager Manufacturing/Process Engineering experience.
• FDA 21 CFR 820 / ISO 13485 experience.
• Experience with PFMEA, DOE, statistical methods and process capability.
• Automation/equipment and fixture development experience.
• Experience with Lean Manufacturing and continuous improvement.
• Experience taking products/processes through development, validation, launch, transfer and sustaining

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.

Este puesto puede cubrirse con un nivel de puesto diferente al indicado aquí, según las necesidades del negocio y/o la experiencia, los conocimientos y las habilidades del candidato o la candidata seleccionado. La compensación se basará principalmente en el nivel del puesto en el que se cubra el rol y en las cualificaciones del candidato o la candidata, de conformidad con la legislación aplicable.