Component Engineer

Intuitive Surgical, Inc.; Sunnyvale (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Intuitive Surgical, Inc. in Sunnyvale, CA seeks a supplier-focused professional to ensure supplier conformance to cost, quality, delivery, and service requirements. You will drive supplier improvement, support NPI and production, and mentor auditors for QMS compliance.

Responsibilities include selecting and qualifying suppliers, managing corrective actions, and leading transfers and strategy for supply networks. This role emphasizes data-driven decisions and cross-functional collaboration.

Responsibilities

• Select, evaluate, and qualify suppliers
• Part qualification including pFMEAs, FAIRS, Cpk, and Control Plans
• Supplier Corrective Action Request initiation, execution, and closure
• Ensure compliance to quality management system and regulatory requirements by leading and mentoring auditors for QMS audits
• Lead detailed projects of transfers of the supply of products and components
• Create strategies to optimize the supply base by leading efforts to optimize supply networks
• Drive suppliers to improve their business and manufacturing process performance to meet ISI requirements including ship to stock programs using best practices in project management, Six Sigma, Lean, SPC and negotiation
• Develop metrics for supplier part cost, delivery, quality, capacity and capability to measure improvement and intervention needs
• Drive corrective actions for supplier processes through root cause analysis and CAPA
• Drive changes to ISI specifications and guide ECO process implementation
• Provide supply base health information to management by delivering data-driven reports and recommendations
• Prepare and deliver supplier communications for scorecards, QBRs, Supplier Summits, etc.
• Facilitate supplier contract development to execution and maintenance in collaboration with the contract team and Supply Chain Management
• Manage the ASL and Global Commodity Matrix
• Work with suppliers and ISI engineering for the new product introduction to determine launch readiness and report to management
• Develop supplier ramp readiness plans based on forecast, capacity, and quality performance
• DFM by engaging suppliers early to feedback manufacturability improvements
• Influence Engineering in supplier selection and lead evaluation of preferred suppliers
• Produce quality deliverables: pFMEA, SPCI, FAI, and CpK through guidance to suppliers

Job description

Company Description

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.

Job Description

Primary Function of Position:

Responsible for ensuring suppliers meet ISI requirements for cost, quality, delivery and service. Drive suppliers to continuously improve business and manufacturing processes. Evaluate and select suppliers. Guide R&D Engineering in choosing suppliers for new products and provide DFM input to new designs. Supports both NPI and on-going production, monitors and works with suppliers to improve supplier performance.

Roles & Responsibilities:

• Select, evaluate, and qualify suppliers


• Part qualification including pFMEAs, FAIRS, Cpk, and Control Plans


• Supplier Corrective Action Request initiation, execution, and closure


• Ensure compliance to quality management system and regulatory requirements by leading and mentoring auditors for QMS audits


• Lead detailed projects of transfers of the supply of products and components


• Create strategies to effectively optimize the supply base by leading efforts to optimize supply networks.


• Drive suppliers to continually improve their business and manufacturing process performance to meet Intuitive Surgical's requirements for supplier excellence including ship to stock programs using a collection of best practices in project management, Six Sigma, Lean, SPC and negotiation by leading these efforts without managerial guidance at several suppliers simultaneously.


• Develop and influence using metrics for supplier part cost, delivery, quality, capacity and capability by creating metrics to measure real improvement and judge required intervention or change at the supplier or in a commodity.


• Drive corrective actions for supplier process by driving suppliers to true root cause analysis and corrective and Preventive actions.


• Drive changes to ISI specifications through influencing and educating resulting in changing specifications and drawings including driving the ECO process to implementation.


• Provide effective and timely supply base health information to management by creating and delivering data-driven supply base information to any level of management at ISI with little or no guidance (including QRB) and provide recommendations.


• Prepare and deliver supplier communications as required by independently working with suppliers on scorecard creation of QBRs, Supplier Summits, etc.


• Facilitate supplier contract development to execution and maintenance by negotiating contracts as necessary in collaboration with the contract team and Supply Chain Management.


• Manage the ASL and Global Commodity Matrix


• Work with suppliers and ISI engineering for the new product introduction to:


• Create product supplier landscapes to determine launch readiness and report to management


• Develop supplier ramp readiness plans by judging business risk based on forecast, supplier capacity, quality performance, and process capability.


• DFM by engaging suppliers early in development cycle to feedback manufacturability improvements in the designs prior to production


• Influence and guide Engineering in choosing suppliers by determining selection criteria for preferred suppliers and leading the team effort to evaluate preferred suppliers.


• Deliver the following Quality deliverables: pFMEA, Special Process Validations, FAI, and Cpk by leading, training and mentoring suppliers through the pFMEA development, judging process validation requirements and signing-off on protocols as ISI rep, judging process capability with supplier as well