Component Engineer

Intuitive Surgical, Inc. in; Sunnyvale (CA); On-site; USD 140,000 - 200,000; Full time

Job summary

Intuitive Surgical seeks a supplier quality and procurement professional responsible for ensuring supplier performance meets cost, quality, delivery and service requirements. Role involves driving continuous improvement, evaluating and qualifying suppliers, and guiding R&D in selecting sources for new products while supporting both NPI and ongoing production.

Responsibilities include leading supplier audits, drive corrective actions, and creating metrics for supplier cost, delivery, quality,

Qualifications

• Experience managing supplier quality in medical devices or complex assemblies.
• Knowledge of pFMEA, FAI, Cpk and control plans.
• Strong ability to drive supplier performance through data and root-cause analysis.

Responsibilities

• Select, evaluate, and qualify suppliers for cost, quality, delivery and service.
• Lead supplier audits to ensure QMS compliance and regulatory requirements.
• Result-driven actions to improve supplier performance and develop contingency plans.
• Drive transfers of product supply and coordinate with ISI engineering for new products.
• Create strategies to optimize supply base and negotiate favorable contracts.
• Develop supplier scorecards, QBRs, and supplier summit communications.

Skills

Supplier management

Quality systems

Audits (QMS)

NPI sourcing

Process improvement (Six Sigma/Lean)

Data-driven decision making

Contract negotiation

Job description

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 as judging FAI suitability.
• Develop the supplier business continuity / disaster recovery plans by managing suppliers to create plans, judge plans for risks and negotiate with suppliers to reduce risks. Identify and investigate opportunities for cost reduction and/or quality improvement by judging opportunities and creating strategies to seize those opportunities, completes research and provides data-driven plans to management.
• Review, analyze and close customer complaints, manufacturing variance requests, and first article inspections by judging risk analyses and justifications, determining corrective and preventive actions at suppliers, looks for opportunities with suppliers to eliminate recurrence.