Manufacturing Engineer 2

Intuitive; Mexicali; In loco; MXN 360.000 - 540.000; Tempo pieno

Descrizione del lavoro

Intuitive is seeking a Manufacturing Engineer to lead Lean implementations and drive continuous improvement across a medical device manufacturing site in a fully onsite role. You will manage tooling, tooling design, and process improvements for precision instruments used in minimally invasive robotic surgery.

The position requires RCA expertise, PFMEA background, and experience with SAP/Agile, ECO reviews, and QMS compliance.

Competenze

• 3 years at least as Manufacturing engineer in medical device company (preferred).
• Strong RCA experience.
• Lean manufacturing tools (yellow belt is a preferred).
• Strong communications skills across team organizations and cultures.
• Strong IQ/OQ/PQ validation protocols background.
• PFMEA.
• Experience with SAP transactions and Agile.
• Review and/or approve ECO (Engineering Change Orders).

Mansioni

• Manufacturing responsibility for tooling/fixtures, manufacturing equipment, and design improvements in production.
• Evaluate and challenge mechanism designs for reliability, functionality, and manufacturability. Provide suggested change proposals.
• Approve design releases to manufacturing, review engineering documentation, and provide vendor and in-house DFM inputs.
• Review/approve and determine the impact of ECOs from manufacturing and field perspectives.
• Take responsibility for developing and maintaining compliance with the quality system.
• Evaluate and help in the selection of suppliers for mechanical parts if required. Help resolve supplier quality issues.
• Update and revise Manufacturing Process Instructions (MPIs) to ensure accuracy and completeness
• Address line support issues as they arise
• Document and report any variances, problems, issues, or concerns on all aspects of the manufacturing process
• Provide production personnel with expectations and performance feedback regularly in the production process
• Drive improvements in safety, quality, production, and cost
• Understand, train personnel, and enforce strict adherence to the applicable Department Operating Procedures (DOPs) and Standard Operating Procedures (SOPs) of the Quality System
• Maintain up-to-date and accessible training records for MPIs and Quality System documents
• Assist in setting and attaining quarterly and annual production goals
• Learn and enforce company safety policies and practices
• Review and disposition of discrepant material in the manufacturing line. Implement corrective actions to prevent recurrences.
• Active participant in quality improvement initiatives, providing feedback to find the root cause and problem-solving.
• Design and documentation responsibilities for custom and standard production tooling/fixtures.
• Process and part design/documentation duties for cost reduction programs.

Conoscenze

Manufacturing experience

RCA experience

Lean manufacturing

Communication skills

IQ/OQ/PQ validation

PFMEA

SAP

Agile

ECO review/approval

Strumenti

SAP

Descrizione del lavoro

• Ways of Working: Onsite - This job is fully onsite.
• Employee Type: Employee
• Global Job Level (HCM): Professional 2 (7)

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:

Contribute your leadership and technical skills in the areas of manufacturing process technologies, problem-solving, training, and project management in a growing medical device company. In this key role, you will be the driving force behind Lean tool implementation and continuous improvement projects site wide. Your combination of training, motivational skills, analytical problem-solving ability, and passion for Lean manufacturing will be just the right fit for the manufacturing environment of precision instruments for minimally invasive robotic surgery.

• Manufacturing responsibility for tooling/fixtures, manufacturing equipment, and design improvements in production.
• Evaluate and challenge mechanism designs for reliability, functionality, and manufacturability. Provide suggested change proposals.
• Approve design releases to manufacturing, review engineering documentation, and provide vendor and in-house DFM inputs.
• Review/approve and determine the impact of ECOs from manufacturing and field perspectives.
• Take responsibility for developing and maintaining compliance with the quality system.
• Evaluate and help in the selection of suppliers for mechanical parts if required. Help resolve supplier quality issues.
• Update and revise Manufacturing Process Instructions (MPIs) to ensure accuracy and completeness
• Address line support issues as they arise
• Document and report any variances, problems, issues, or concerns on all aspects of the manufacturing process
• Provide production personnel with expectations and performance feedback regularly in the production process
• Drive improvements in safety, quality, production, and cost
• Understand, train personnel, and enforce strict adherence to the applicable Department Operating Procedures (DOPs) and Standard Operating Procedures (SOPs) of the Quality System
• Maintain up-to-date and accessible training records for MPIs and Quality System documents
• Assist in setting and attaining quarterly and annual production goals
• Learn and enforce company safety policies and practices
• Review and disposition of discrepant material in the manufacturing line. Implement corrective actions to prevent recurrences.
• Active participant in quality improvement initiatives, providing feedback to find the root cause and problem-solving.
• Design and documentation responsibilities for custom and standard production tooling/fixtures.
• Process and part design/documentation duties for cost reduction programs.

Required Skills and Experience:

• 3yearsatleastasManufacturingengineerinamedicaldevicecompany(preferred)
• StrongRCAexperience
• Leanmanufacturingtools(yellowbeltisapreferred)
• Strongcommunicationsskillsacrossteamorganizationsandcultures.
• StrongIQ/QO/PQValidationprotocolsbackground
• PFMEA
• ExperiencewithSAPtransactionsandAgile.
• Reviewand/orapproveECO(EngineeringChangeOrders)

RequiredEducationandTraining