Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Requisition ID: 200419
Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and
decreasing surgical invasiveness, with patient safety as our highest priority.
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 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 and Responsibilities:
This position has responsibility and authority to:
• Select, evaluate, and qualify fiber optic suppliers and others• 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:
o Create product supplier landscapes to determine launch readiness and report to managemento Develop supplier ramp readiness plans by judging business risk based on forecast, supplier capacity, quality performance, and process capability.o DFM by engaging suppliers early in development cycle to feedback manufacturability improvements in the designs prior to productiono Influence and guide Engineering in choosing suppliers by determining selection criteria for preferred suppliers and leading the team effort to evaluate preferred suppliers.o 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.
Qualifications• 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.• Other reasonable duties
In order to adequately perform the responsibilities of this position the individual must possess:
• BS degree in Engineering or equivalent, experience in Fiber Optics preferred• Minimum 10 years related experience in Supplier Quality and/or Supplier Development or related field• Excellent written and verbal communication skills including presentations to executive level management• Excellent Interpersonal skills and team building skills• A proven history of implementing Lean/6 Sigma/SPC Programs at suppliers• Excellent Project Management skills• Excellent analytical and problem solving skills along with good judgment• Demonstrable knowledge in evaluating and challenging supplier technical, quality, and business capabilities• Demonstrable knowledge of a wide range of manufacturing processes including understanding of key input variables for quality, cost and capacity (specialization can be in metal fabrication, plastics, electronics, and/or contract manufacturing)• Excellent knowledge of 21 CFR part 820 and ISO 13485 (experience in auditing suppliers to these standards)• Significant computer experience using Windows, Word, Excel, Access and ERP Information Systems, preferably SAP• CAD experience with 3D modeling tools is a plus• Proven ability to motivate suppliers• Experience in a high-volume medical device company is a plus• Ability to read and interpret detailed mechanical drawings and communicate technical information• Ability to travel to suppliers on an as needed basis – domestic and international
We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.