Senior Medical Device Supply Chain Engineer

Intuitive Surgical, Inc.; Sunnyvale (CA); On-site; USD 161,000 - 231,000; Full time

Job summary

Intuitive Surgical, Inc. in Sunnyvale, CA is seeking a senior Supplier Engineering/Quality professional to ensure suppliers meet cost, quality, delivery and service requirements.

You will drive supplier improvement, evaluate and qualify vendors, and guide R&D in selecting suppliers for new products, providing DFM input to designs and supporting both NPI and ongoing production. This role requires extensive experience with Lean/ Six Sigma, ISO 13485, and FDA quality systems, plus travel to

Qualifications

• BS degree in Engineering or equivalent, experience in catheter development preferred
• Minimum 10 years related experience in Supplier Engineering/Development/Quality 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

Responsibilities

• Select, evaluate, and qualify suppliers
• Part qualification including pFMEAs, FAIRS, Cpk, and Control Plans
• Machine Components experience highly preferred
• Experience with Catheter experience, cables, laser welding and endoscopes
• Experience building supply chain support or evaluating
• 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 ISI 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

Skills

Supplier Engineering

Quality Assurance

Project Management

Communication

Lean/Six Sigma

Regulatory Knowledge

Education

BS degree in Engineering

Tools

SAP

ERP

CAD

Job description

Intuitive Surgical, Inc. in Sunnyvale, CA is seeking a senior Supplier Engineering/Quality professional to ensure suppliers meet cost, quality, delivery and service requirements.

You will drive supplier improvement, evaluate and qualify vendors, and guide R&D in selecting suppliers for new products, providing DFM input to designs and supporting both NPI and ongoing production. This role requires extensive experience with Lean/ Six Sigma, ISO 13485, and FDA quality systems, plus travel to