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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. Monitor supplier performance.
Roles and Responsibilities:
This position has responsibility and authority to:
* Ensure the part and product compliance with predetermined specification is met by selecting, developing and establishing capable processes at the supplier. * Ensure the supplier inspection plans and ISI incoming inspection are implemented correct and reflective of the supplier capability . * Works with suppliers and ISI engineering for introduction of new supplier or changes to the products to
oDFM by engaging suppliers early in the development cycle to deliver feedback on manufacturability improvements in the designs prior to production.
oGuide Engineering in choosing suppliers with input from management by determining selection criteria for Preferred Suppliers and also by leading the team effort to evaluate Preferred Suppliers.
oDeliver the following Quality deliverables: pFMEA, Special Process Validations, FAI, and Cpk.by leading suppliers through the pFMEA development, judging process validation requirements and sign off on protocols as an ISI representative, judging process capability with supplier and judging FAI suitability.
* 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 with little managerial guidance at several suppliers simultaneously. * 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, looking for opportunities with suppliers to eliminate recurrence. * Ensure compliance to quality management system and regulatory requirements by performing as the lead auditor for QMS audits. * Participate in detailed projects for the supply of products and components by managing a key segment deliverable of the project and participating as a member of the team. * Create strategies to effectively optimize the supply base by leading efforts to optimize portions of the supply network. * Develop and use metrics for supplier part cost, delivery, quality, capacity and capability by creating metrics to judge required intervention or change at a supplier or in a commodity. * Drive corrective actions for supplier process by being proficient in the five whys, determining true root cause, corrective and preventive actions. * Driving change to ISI specifications as necessary by proposing changes to specifications and drawings including driving the ECO process to implementation. * Provide effective and timely supply base health information to management by creating data-driven supply base information and delivering information to any level of management at ISI with minimal guidance (including QRB). * Facilitate supplier contract development to execution and maintenance by being part of the negotiating team for contracts as necessary with the contract team and Supply Chain Management. * Manage the ASL within ISI with Engineering and Purchasing. * Identify and investigate opportunities for cost reduction and/or quality improvement by collecting opportunities and creating tactics to present opportunities, performs research, and provides data-driven plans to management.
In order to adequately perform the responsibilities of this position the individual must possess:
* BS degree in Engineering or equivalent * 5-10 years related experience in Supplier Quality, Supplier Development, Manufacturing Engineering, Quality Engineering, or related field * Excellent written and verbal communication skills * A proven history of implementing Lean/6 Sigma/SPC Programs at suppliers * Excellent Project Management skills * Excellent analytical 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.