Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Requisition ID: 200527
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:
This individual will be 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 Design engineering in choosing suppliers for new products and provide DFM input to new designs. Monitor supplier performance.
Roles and Responsibilities:
This position has responsibility and authority to:
• Work with suppliers and Intuitive Design and Manufacturing Engineering to
o Perform DFM by engaging suppliers early in development cycle to feedback manufacturability improvements in the designs prior to productiono Complete part production qualification process (PPQP), which includes but not limited to delivering on the following deliverables: spFMEA, Process Validations, Process capability (Cpk and Ppk), MSA, capacity analysis, and FAIR .o Develop supplier ramp readiness based on forecast, supplier capacity, quality performance, and process capability.
Qualifications• Drive change to ISI specifications as necessary by understanding and changing specifications and drawings including driving the ECO process to implementation.• Utilize knowledge of GD&T principles to appropriately specify and inspect design requirements.• 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.• 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.• Select and evaluate suppliers by leading efforts to find new suppliers in an existing or new commodity.• Lead and resolve the supply continuity/ quality issues at suppliers through in depth root cause and corrective actions utilizing SCARs, SCRs (Supplier Change requests) processes.• Develop and use 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.• Prepare and deliver supplier communications as required by independently working with suppliers on scorecard creation of QBRs etc.
In order to adequately perform the responsibilities of this position the individual must possess:
• BS degree in Engineering or equivalent, Master’s degree preferred• 8 or more years of related experience in Design Engineering, Manufacturing Engineering, Supplier Engineering, Supplier Quality and/or Supplier Development or related field• Excellent knowledge of 21 CFR part 820 and ISO 13485 (experience in auditing suppliers to these standards): Certified Lead auditor preferred, but not required• In depth knowledge of PFMEA, process capability (Cpk) and process validations (IQ, OQ and PQ)• Good understanding of Metals and Plastics manufacturing. (MIM, Machining, Injection Molding, extrusion, braiding, over-molding, stamping etc.)• Ability to read and interpret detailed mechanical drawings and communicate technical information• Willing to lead projects and work cross functionally with different groups. Highly motivated individual.• Excellent problem solving and project management skills• Excellent written and verbal communication skills including presentations to executive level management• Practical knowledge of part production qualification process• 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 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.