Staff Supplier Engineer
Responsibilities: · As an expert in the field, use professional concepts in developing resolution to critical issues and broad design matters. Experience leading departmental and cross functional projects and teams. Significant experience turning innovative ideas into real products and solutions. · Complete project/ part qualification deliverables including: Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis · Work with suppliers to execute cost reductions, capacity improvements, and risk mitigation · Select the right process and supplier for the part, considering long term fit and total cost of ownership · Expertly translates complex technical problems into solutions. Integral technical advisor to senior leaders. · Manage complex supplier changes including manufacturing process changes, production optimization, facility changes, new equipment qualification, and new line validations · Drive changes to ISI requirements as necessary by initiating and managing changes to specifications and drawings through the engineering change order process · Works on issues that impact design/selling success or address future concepts, products or technologies. Creates formal networks with key decision makers and serves as external spokesperson for the organization. · Own and drive to closure supplier variances from symptom through root cause analysis to corrective action, including  up to SCAR documentation · Effectively prioritize and advance multiple concurrent high priority projects and tasks · Effectively integrates and distills communications across multiple teams and activities for cohesive and unified messaging within teams and across ISI · Build, own, and relentlessly pursue a vision for developing suppliers · Understand proper level of documentation detail for tracking of actions and justification of decisions · Generate key metrics for the team and suppliers, and continually drive for timely achievement of those metrics · Drive suppliers to continually improve their business and manufacturing process performance to meet Intuitive’s requirements for supplier excellence using a collection of best practices in project management, Six Sigma, Lean, SPC and negotiation. Lead these efforts without managerial guidance at several suppliers simultaneously · Implement corrective and preventive actions for supplier process by driving supplier’s investigations and root cause analysis · Provide effective and timely supply base health information and recommendation to management by creating and delivering data-driven supply base information to any level of management at ISI with little or no guidance · Prepare and deliver supplier communications as required by independently working with suppliers on scorecard creation · 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 · Review, analyze and close customer complaints, manufacturing variance requests, and first article inspections by judging risk analyses and justifications · Evaluate corrective and preventive actions at suppliers, looks for opportunities with suppliers to eliminate recurrence · Other reasonable duties
Skills, Experience, Education, & Training: • Minimum Education: MS degree in Mechanical or Biomedical Engineering or equivalent experience • Minimum 12 years related experience in engineering and manufacturing of machined metal or plastic injection molding parts. Complex electrical and fiberoptic cabling manufacturing and Metal injection molding experience is highly desirable • 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 sound 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 • Significant computer experience using Windows, Word, Excel, Project, Access, and ERP Information Systems, preferably SAP or Agile • CAD experience with 3D modeling tools is a plus • Experience with statistical analysis software such as Minitab 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 (GD&T) and communicate technical information • Ability to travel to suppliers on an as needed basis – domestic and international (approx 25%)
It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive . As a global leader in robotic-assisted surgery and minimally invasive care , our technologies—like the da Vinci surgical system and Ion —have transformed how care is delivered for millions of patients worldwide. We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perf
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