NPI Supplier Engineer - Ion

Intuitive•Sunnyvale, CA

About The 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 collaborate on supplier selection with cross functional partners. Supports sustaining production, monitors and engages with suppliers to improve supplier performance.

Requirements

BS degree in Engineering or equivalent, experience in catheter development preferred
Minimum 5 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
Proven ability to motivate suppliers
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

Nice To Haves

CAD experience with 3D modeling tools is a plus
Experience in a high-volume medical device company is a plus

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
Partner with global supply chain to optimize the supply base
Drive suppliers to continually improve their business and manufacturing process performance to meet Intuitive Surgical requirements for supplier excellence including ship to stock programs using a collection of best practices in project management, Six Sigma, Lean, SPC and negotiation
Utilize data-driven decisions to evaluate supplier part cost, delivery, quality, capacity and capability. Apply 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.
Provide effective and timely supply base health information to management
Prepare and deliver supplier communications as required by working with suppliers on scorecard creation of QBRs, Supplier Summits, etc.
Manage the ASL and Global Commodity Matrix
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 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.