Manufacturing Engineering Manager

Intuitive; Mexicali; Sur place; MXN 900 000 - 1 200 000; Plein temps

Résumé du poste

Intuitive is seeking a Manufacturing Engineering Manager to lead the strategy and execution of the manufacturing engineering area, ensuring reliability, cost efficiency, manufacturability and serviceability for instruments and accessories.

You will manage resources, coordinate activities, and provide mechanical/manufacturing support per FDA 21 CFR820 and ISO 13485. Travel may be required to support suppliers and projects.

Qualifications

• Minimum 3 years of direct people management within Manufacturing Engineering.
• Includes performance coaching and prioritization of engineering resources.
• Experience leading cross-functional teams across Manufacturing Engineering, Operations, Quality, NPI and support functions.

Responsabilités

• Lead yield improvement, material cost reduction, capacity enhancement, and outsourcing of assemblies.
• Evaluate mechanism designs for reliability, serviceability and manufacturability; propose changes.
• Create budget estimates for tooling, test equipment, prototypes and first articles.
• Ensure processes meet specifications and avoid variations in manufacturing.
• Provide failure analysis for discrepant components and field returns.
• Qualify, document and introduce production processes.
• Maintain compliance with the quality system and regulatory requirements.
• Evaluate and select suppliers; resolve supplier quality issues.
• Interface with product development, planning, purchasing, regulatory, and marketing teams.

Connaissances

People management

Cross-functional leadership

Mechanical engineering

Process engineering

Root cause analysis

Communication skills

Resource prioritization

Leadership

Formation

MS degree in Engineering

Outils

PFMEA

DOE

IQ/OQ/PQ/PPQ

Statistical methods

Process capability

Description du poste

• Ways of Working: Onsite - This job is fully onsite.


• Employee Type: Employee


• Global Job Level (HCM): Management 3, Mgr (12)

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.

• 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

• ManufacturingEngineeringManagerbackgroundrequired


• Minimum3yearsofdirectpeoplemanagementexperiencewithinManufacturingEngineering,includingperformancemanagement,coaching,employeedevelopmentandprioritizationofengineeringresources.


• Demonstratedabilitytoleadcross-functionalteamsacrossManufacturingEngineering,Operations,Quality,NPIandothersupportingfunctions.


• DemonstratedMechanicaland/orProcessEngineeringtechnicalcapability.


• Strongexperienceinrootcauseanalysis,correctiveactions,processimprovementandproblemsolving.


• Experiencewithprocess/equipmentvalidationandqualification(IQ/OQ/PQ/PPQ).


• DemonstratedownershipofmanufacturingKPIssuchasYield,Quality,Throughput,Capacity,Scrap/CostandEquipmentPerformance.


• Demonstratedabilitytoprioritizemultiplecompetingbusinessneeds,driveaccountabilityanddeliverresultsthroughateam.


• Strongcommunicationandescalationskillswiththeabilitytoinfluenceacrossfunctionsandorganizationallevels.


• MedicalDevicemanufacturingexperiencestronglypreferred.

Preferred:

• MSdegreeinanEngineeringdiscipline.


• 7-8+yearsofManagerManufacturing/ProcessEngineeringexperience.


• FDA21CFR820/ISO13485experience.


• ExperiencewithPFMEA,DOE,statisticalmethodsandprocesscapability.


• Automation/equipmentandfixturedevelopmentexperience.


• ExperiencewithLeanManufacturingandcontinuousimprovement.


• Experiencetakingproducts/processesthroughdevelopment,validation,launch,transferandsustaining